Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000430
Status:
TERMINATED
Last Update Posted:
2007-01-04
First Post:
2000-01-18
Brief Title:
Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Clinical Trial of Continuous Low-Dose Hormone Replacement Therapy Combined With Alendronate in Postmenopausal Women With Low Bone Density
Status:
TERMINATED
Status Verified Date:
2004-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Osteoporosis a condition in which bones are fragile and break easily is a major health problem for postmenopausal women Research studies have shown that both estrogenprogestin replacement therapy hormone replacement therapy or HRT and alendronate are effective in preventing and treating osteoporosis However because these drugs work in somewhat different ways a combination of the two drugs might protect women from osteoporosis better than either drug alone In this study we will test whether HRT and alendronate given together for 35 years to postmenopausal women with low bone mass will have a greater effect on bone than either HRT or alendronate given alone We will also give every participant in this study calcium and vitamin D supplements
Detailed Description:
Clinical trials of estrogenprogestin replacement therapy HRT and a bisphosphonate alendronate ALN have demonstrated that both are effective in causing gains in bone mass and preventing bone loss and fractures in postmenopausal women The FDA has approved both these drugs for prevention and treatment of fractures and both are widely used in clinical practice Because both are approved and effective and they work by different mechanisms many patients and their physicians ask whether both should be taken in combination particularly in cases of severe disease The question is asked frequently because of the high incidence of osteoporosis among women and the need for long-term prevention and treatments that often last decades
Indeed physicians are using ALN and HRT together without adequate scientific support for the assumption that the combination is more effective than either given alone
Clinical trials are now underway to test conventional doses of HRT given as conjugated equine estrogens CEE 0625 mgday or its equivalent combined with ALN 10 mgday However researchers are not studying the bone-sparing effectiveness of the combined administration of ALN and low-dose continuous HRT given as CEE 03 mgd along with medroxyprogesterone 25 mgd MP This low-dose continuous HRT regimen is attractive because of better convenience better patient tolerance and reduced risk of breast cancer and other safety concerns associated with conventional higher doses Further we have recently demonstrated that the bone-sparing effect of this regimen is comparable to that of higher doses
The long-term objective of this study is to test the hypothesis that the combined therapy shows a greater bone effect than does either treatment given alone Our specific aim is to conduct a 35 year randomized double-blind controlled trial of low-dose continuous HRT combined with alendronate 10 mgd ALN in three groups 72 people per group of estrogen-deprived postmenopausal women over age 60 We will give Group 1 low-dose HRT Group 2 ALN and Group 3 both low-dose HRT and ALN We will give calcium and vitamin D supplements to people in all three groups
The primary outcome measures will be spine bone mineral density SpBMD and total hip bone mineral density HipBMD measured by dual energy X-ray absorptiometry DXA Secondary outcome measures will be total body bone mineral content and forearm bone mineral content In addition we will perform studies to characterize the mechanism of the effects of these regimens These studies will consist of measurements of urinary bone resorption markers serum bone formation markers calcium excretion calcium absorption and application of a model developed in our laboratory to estimate and compare the magnitudes of the anabolic effects if any of all three interventions on SpBMD and HipBMD
We have reported data showing that both agents have an anabolic effect on bone in humans meaning that they cause an increase in bone mass beyond that explained by a remodeling transient brought about by reduction in bone remodeling rates Further research has shown that HRT and ALN affect bone by different mechanisms Thus this combination may have an additive effect on bone resulting in bone gain beyond that previously seen with other interventions This project will provide much-needed information to physicians and their patients on the benefits and safety of this combination regimen so that they can make evidence-based decisions on the choice of interventions to prevent and treat osteoporosis
Indeed physicians are using ALN and HRT together without adequate scientific support for the assumption that the combination is more effective than either given alone
Clinical trials are now underway to test conventional doses of HRT given as conjugated equine estrogens CEE 0625 mgday or its equivalent combined with ALN 10 mgday However researchers are not studying the bone-sparing effectiveness of the combined administration of ALN and low-dose continuous HRT given as CEE 03 mgd along with medroxyprogesterone 25 mgd MP This low-dose continuous HRT regimen is attractive because of better convenience better patient tolerance and reduced risk of breast cancer and other safety concerns associated with conventional higher doses Further we have recently demonstrated that the bone-sparing effect of this regimen is comparable to that of higher doses
The long-term objective of this study is to test the hypothesis that the combined therapy shows a greater bone effect than does either treatment given alone Our specific aim is to conduct a 35 year randomized double-blind controlled trial of low-dose continuous HRT combined with alendronate 10 mgd ALN in three groups 72 people per group of estrogen-deprived postmenopausal women over age 60 We will give Group 1 low-dose HRT Group 2 ALN and Group 3 both low-dose HRT and ALN We will give calcium and vitamin D supplements to people in all three groups
The primary outcome measures will be spine bone mineral density SpBMD and total hip bone mineral density HipBMD measured by dual energy X-ray absorptiometry DXA Secondary outcome measures will be total body bone mineral content and forearm bone mineral content In addition we will perform studies to characterize the mechanism of the effects of these regimens These studies will consist of measurements of urinary bone resorption markers serum bone formation markers calcium excretion calcium absorption and application of a model developed in our laboratory to estimate and compare the magnitudes of the anabolic effects if any of all three interventions on SpBMD and HipBMD
We have reported data showing that both agents have an anabolic effect on bone in humans meaning that they cause an increase in bone mass beyond that explained by a remodeling transient brought about by reduction in bone remodeling rates Further research has shown that HRT and ALN affect bone by different mechanisms Thus this combination may have an additive effect on bone resulting in bone gain beyond that previously seen with other interventions This project will provide much-needed information to physicians and their patients on the benefits and safety of this combination regimen so that they can make evidence-based decisions on the choice of interventions to prevent and treat osteoporosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-040 | None | None | None |