Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-05 @ 2:48 AM
Study NCT ID:
NCT01950169
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
2013-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068296', 'term': 'Risedronic Acid'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D002118', 'term': 'Calcium'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lena.flodin@sll.se', 'phone': 'Mobile: 0701910300', 'title': 'Dr. Lena Flodin', 'organization': 'Department of Geriatric Medicine, Karolinska University Hospital, Stockholm, Sweden'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected 1 year for every patient included.', 'description': 'Once a month the study research nurse interviewed patients by telephone regarding compliance, general state of health and collected adverse event information.', 'eventGroups': [{'id': 'EG000', 'title': 'B, Bisphosphonate', 'description': 'Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 2, 'seriousNumAtRisk': 28, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BN/N, Bisphosphonate Along With Nutritional Supplementation', 'description': 'Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily).', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'C, Control', 'description': 'The patients were randomized to receive calcium and vitamin D3 alone and served as controls.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 3, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation/diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'B, Bisphosphonate', 'description': 'Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily.'}, {'id': 'OG001', 'title': 'BN/N, Bisphosphonate Along With Nutritional Supplementation', 'description': 'Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily).'}, {'id': 'OG002', 'title': 'C, Control', 'description': 'The patients were randomized to receive calcium and vitamin D3 alone and served as controls.'}], 'classes': [{'title': 'follow up at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.008', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.026', 'groupId': 'OG001'}, {'value': '-0.017', 'spread': '0.026', 'groupId': 'OG002'}]}]}, {'title': 'follow up at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.012', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '-0.004', 'spread': '0.025', 'groupId': 'OG001'}, {'value': '-0.018', 'spread': '0.032', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates used were age, sex, total mass, and baseline BMD. Data were reported using complete-cases analysis and intention-to-treat (ITT) analysis.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Total hip bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm\\^2). The change in BMD between baseline, 6 and 12 months was registered.', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up.'}, {'type': 'PRIMARY', 'title': 'Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'B, Bisphosphonate', 'description': 'Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily. Total hip and total body BMD were assessed with dual-energy X-ray absorptiometry at baseline, 6.and 12 months.'}, {'id': 'OG001', 'title': 'BN/N, Bisphosphonate Along With Nutritional Supplementation', 'description': 'Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily).'}, {'id': 'OG002', 'title': 'C, Control', 'description': 'The patients were randomized to receive calcium and vitamin D3 alone and served as controls.'}], 'classes': [{'title': 'follow-up at 6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '-0.006', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '-0.012', 'spread': '0.019', 'groupId': 'OG002'}]}]}, {'title': 'follow-up at 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '0.0006', 'spread': '0.019', 'groupId': 'OG001'}, {'value': '-0.017', 'spread': '0.020', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covariates used were age, sex, total mass, and baseline BMD. Data were reported using complete-cases analysis and intention-to-treat (ITT) analysis.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Total body mineral density (BMD) were assessed by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm\\^2). The change in BMD between baseline, 6 and 12 months was registered.', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up.'}, {'type': 'SECONDARY', 'title': 'Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'B, Bisphosphonate', 'description': 'Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily. Total hip and total body BMD were assessed with dual-energy X-ray absorptiometry at baseline, 6.and 12 months.'}, {'id': 'OG001', 'title': 'BN/N, Bisphosphonate Along With Nutritional Supplementation', 'description': 'Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily).'}, {'id': 'OG002', 'title': 'C, Control', 'description': 'The patients were randomized to receive calcium and vitamin D3 alone and served as controls.'}], 'classes': [{'title': 'follow up at 6 months', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'follow up at 12 months', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The analyses included exposure measures treatment groups and sex as fixed factors. Age and baseline values for FFMI, FMI were included as covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up. The sum of lean mass (LM) and BMC represents fat-free mass (FFM). To normalize for body size, FFM was divided by height squared to calculate fat-free mass index (FFMI, kg/m\\^2).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up. Calculations revealed that a sample size of 40 patients per group was required to detect a difference in lean mass between groups (power = 80 %, a = 0.05). However, the study was closed after 4 years due to difficulties in recruiting patients and the study was switched to an exploratory design.'}, {'type': 'SECONDARY', 'title': 'Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'B, Bisphosphonate', 'description': 'Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily. Total hip and total body BMD were assessed with dual-energy X-ray absorptiometry at baseline, 6.and 12 months.'}, {'id': 'OG001', 'title': 'BN/N, Bisphosphonate Along With Nutritional Supplementation', 'description': 'Patients were randomized to treatment with bisphosphonates along with nutritional supplementation (40 gram protein, 600 kcal daily).'}, {'id': 'OG002', 'title': 'C, Control', 'description': 'The patients were randomized to receive calcium and vitamin D3 alone and served as controls.'}], 'classes': [{'title': 'follow up at 6 months', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'follow up at 12 months', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '1.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up.To normalize for body size, FM was divided by height squared to calculate fat mass index (FMI, kg/m\\^2).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Seventy-nine patients were initially included in the study, of whom 67 were available at final follow-up. Calculations revealed that a sample size of 40 patients per group was required to detect a difference in lean mass between groups (power = 80 %, a = 0.05). However, the study was closed after 4 years due to difficulties in recruiting patients and the study was switched to an exploratory design.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group B, Bisphosphonates', 'description': 'Patients allocated to intervention B received 35 mg risedronate once weekly for 12 months and 1,000 mg calcium and 800 IU vitamin D3 daily.'}, {'id': 'FG001', 'title': 'Group BN/N, Bisphosphonates Along With Nutritional Supplementation', 'description': 'Patients allocated to intervention BN/N received 35 mg risedronate once weekly for 12 months plus a nutritional supplement (Fresubin protein energy drink) during the first 6 months after hip fracture. The supplement contained 150 kcal and 10 g protein/100 mL milk-based protein (80 % casein and 20 % whey). Patients were prescribed 200 mL twice daily, totaling 600 kcal with 40 g protein.'}, {'id': 'FG002', 'title': 'Group C, Control', 'description': 'Patients allocated to group C served as controls and received 1,000 mg Calcium and 800 IU vitamin D3 daily for 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group B, Bisphosphonate', 'description': 'Patients were randomized to treatment with bisphosphonates (risedronate 35 mg weekly for 12 months. All patients received calcium (1,000 mg) and vitamin D3 (800 IU) daily.'}, {'id': 'BG001', 'title': 'Group BN/N, Bisphosphonates Along With Nutritional Supplementation', 'description': 'Patients allocated to intervention BN/N received 35 mg risedronate once weekly for 12 months plus a nutritional supplement (Fresubin protein energy drink) during the first 6 months after hip fracture. The supplement contained 150 kcal and 10 g protein/100 mL milk-based protein (80 % casein and 20 % whey). Patients were prescribed 200 mL twice daily, totaling 600 kcal with 40 g protein.'}, {'id': 'BG002', 'title': 'C, Control', 'description': 'Patients allocated to group C served as controls and received 1,000 mg Calcium and 800 IU vitamin D3 daily for 12 months.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000', 'lowerLimit': '63', 'upperLimit': '94'}, {'value': '82', 'groupId': 'BG001', 'lowerLimit': '62', 'upperLimit': '93'}, {'value': '75', 'groupId': 'BG002', 'lowerLimit': '61', 'upperLimit': '96'}, {'value': '81', 'groupId': 'BG003', 'lowerLimit': '61', 'upperLimit': '96'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients who were admitted to one of the four university hospitals in Stockholm, Sweden during 2005-2009, with the diagnosis of femoral neck or trochanteric fracture.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-20', 'studyFirstSubmitDate': '2013-09-23', 'resultsFirstSubmitDate': '2020-11-08', 'studyFirstSubmitQcDate': '2013-09-23', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-20', 'studyFirstPostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Hip Bone Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Total hip bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm\\^2). The change in BMD between baseline, 6 and 12 months was registered.'}, {'measure': 'Total Body Mineral Density (BMD) at Baseline, 6 and 12 Months After Hip Fracture.', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Total body mineral density (BMD) were assessed by dual-energy X-ray absorptiometry (DXA). The DXA image is two dimensional and BMD was expressed as areal density, grams per square centimeter (g/cm\\^2). The change in BMD between baseline, 6 and 12 months was registered.'}], 'secondaryOutcomes': [{'measure': 'Body Composition, Including Lean Mass at Baseline, 6 and 12 Months After Hip Fracture.', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up. The sum of lean mass (LM) and BMC represents fat-free mass (FFM). To normalize for body size, FFM was divided by height squared to calculate fat-free mass index (FFMI, kg/m\\^2).'}, {'measure': 'Body Composition, Including Fat Mass at Baseline, 6 and 12 Months After Hip Fracture.', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Total body composition, including lean mass composed of muscle, visceral organs and water (LM), fat mass (FM) and bone mineral content (BMC) was measured by dual-energy X-ray absorptiometry (DXA) at baseline and at 6 and 12 months follow up.To normalize for body size, FM was divided by height squared to calculate fat mass index (FMI, kg/m\\^2).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hip fracture', 'Nutritional supplement', 'Bisphosphonates', 'Bone mineral density', 'Body composition'], 'conditions': ['Hip Fracture']}, 'referencesModule': {'references': [{'pmid': '26572609', 'type': 'DERIVED', 'citation': 'Flodin L, Cederholm T, Saaf M, Samnegard E, Ekstrom W, Al-Ani AN, Hedstrom M. Effects of protein-rich nutritional supplementation and bisphosphonates on body composition, handgrip strength and health-related quality of life after hip fracture: a 12-month randomized controlled study. BMC Geriatr. 2015 Nov 17;15:149. doi: 10.1186/s12877-015-0144-7.'}]}, 'descriptionModule': {'briefSummary': 'The study hypothesis is that nutritional supplementation together with bisphosphonates have a better preserving effect on bone mineral density (BMD) after hip fracture than bisphosphonates alone and that nutritional supplementation given postoperatively for 6 months preserve lean body mass in elderly hip fracture patients.', 'detailedDescription': 'Inclusion criteria: Men and women, ≥ 60 years of age with a recent fracture of the femoral neck or trochanter, admitted to any of the four University hospitals in Stockholm, Sweden. Patients are randomized into three groups by sealed enveloped technique in blocks by 12, thus assuring that each center had an equal distribution of patients in the three treatment groups. Patients randomly assigned and followed for 12 months. Each center with a doctor in charge and a trial nurse. The trial nurse in collaboration with the doctor are responsible of the randomization procedure and that blood samples are taken in the morning of the first weekday after inclusion at the ward and further that the dual-energy X-ray (DXA) and all estimates are done during hospital stay.The pharmacological treatment and nutritional supplementation starts as soon as the patients are circulatory stable, able to take food by mouth and are able to sit in an upright position one hour after taking the tablets.Patients are examined at baseline with a follow up at 6 and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 60 years\n* Recent fracture of the femoral neck or trochanter\n* Without severe cognitive impairment\n* Ambulant before fracture\n* BMI ≤ 28\n\nExclusion Criteria:\n\n* Abnormal parameters regarding liver i.e. S-Alanine aminotransferase (S-ALAT) and S-Aspartate aminotransferase (S-ASAT) ≥ twice as normal\n* Abnormal parameters regarding kidney i.e. S-Creatinine \\> 130 µg/L\n* Primary hyperparathyroidism, osteogenesis imperfecta, Paget´s disease\n* Myeloma\n* Lactose intolerance\n* Dysphagia\n* Esophagitis\n* Gastric ulcer\n* Malignancy\n* Diabetes with nephropathy or retinopathy\n* Active iritis or uveitis'}, 'identificationModule': {'nctId': 'NCT01950169', 'briefTitle': 'Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture', 'orgStudyIdInfo': {'id': 'NutristudienSHFG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Risedronate', 'description': '35 mg risedronate orally administered once weekly for 12 months and orally administered Calcium 1000 mg and 800 IU vitamin D3 daily for 12 months. Group B (bisphosphonate group)', 'interventionNames': ['Drug: Risedronate', 'Dietary Supplement: Calcium and vitamin D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nutritional supplement', 'description': 'Oral liquid nutritional supplement (600kcal and 40 gram protein/day) for 6 months after the hip fracture besides Risedronate and calcium and vitamin D3. Group BN (bisphosphonate and nutritional supplemented group)', 'interventionNames': ['Drug: Risedronate', 'Other: Nutritional supplement', 'Dietary Supplement: Calcium and vitamin D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calcium and vitamin D3', 'description': 'An oral dose of 1000 mg Calcium and 800 IU vitamin D3 daily for 12 months after hip fracture. Group C (control)', 'interventionNames': ['Dietary Supplement: Calcium and vitamin D3']}], 'interventions': [{'name': 'Risedronate', 'type': 'DRUG', 'otherNames': ['Bisphosphonate Group (B)'], 'description': 'The bisphosphonate group (B) receive 35 mg risedronate (Optinate® Septimum) once weekly for 12 months and calcium (1000 mg) and vitamin D3 (800 IU) (Calcichew-D3®) daily for 12 months.', 'armGroupLabels': ['Nutritional supplement', 'Risedronate']}, {'name': 'Nutritional supplement', 'type': 'OTHER', 'otherNames': ['Bisphosphonate and nutritional supplemented Group (BN)'], 'description': 'The bisphosphonate and nutritional supplemented group (BN) receive 35 mg risedronate once weekly for 12 months plus nutritional supplement (Fresubin® protein energy drink) during the first six months following hip fracture and also calcium (1000 mg) and vitamin D3 (800 IU) daily for 12 months.', 'armGroupLabels': ['Nutritional supplement']}, {'name': 'Calcium and vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Control Group (C)'], 'description': 'The patients in the control group (C) receive orally administered calcium 1000 mg and 800 IU vitamin D3 (Calcichew-D3®) daily for 12 months.', 'armGroupLabels': ['Calcium and vitamin D3', 'Nutritional supplement', 'Risedronate']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of Geriatric Medicine R94, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Margareta Hedström, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Maria Sääf, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Lena Flodin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Lena Flodin', 'investigatorAffiliation': 'Karolinska Institutet'}}}}