Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
---|---|
Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00000400 |
This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.
Condition | Intervention | Phase |
---|---|---|
Osteoporosis |
Drug: Human parathyroid hormone [hPTH-(1-34)] Drug: alendronate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Bone Formation-Resorption Coupling and Osteoporosis |
Enrollment: | 176 |
Study Start Date: | August 1999 |
Study Completion Date: | June 2006 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
PTH: Experimental
Human parathyroid hormone [hPTH-(1-34)]
|
Drug: Human parathyroid hormone [hPTH-(1-34)]
37 mcg once daily by self-administered sc injection
|
ALN: Active Comparator
Alendronate
|
Drug: alendronate
70 mg/week by oral route
|
PTH+ALN: Experimental
Human parathyroid hormone [hPTH-(1-34)] plus alendronate
|
Drug: Human parathyroid hormone [hPTH-(1-34)]
37 mcg once daily by self-administered sc injection
Drug: alendronate
70 mg/week by oral route
|
This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily (Phase A, months 0-30).
Participants who complete Phase A are eligible for a 12 month extension study (Phase B, months 30-42), during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped.
Participants who complete Phase B are eligible for a second 12 month extension study (Phase C, months 42-54), during which any alendronate treatment is continued without change and every participant takes hPTH 1-34.
During Phases B and C, these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass.
Ages Eligible for Study: | 45 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Robert M. Neer, MD | Massachusetts General Hospital |
Responsible Party: | Endocrine Unit, Massachusetts General Hospital ( Robert M. Neer, MD ) |
Study ID Numbers: | P50 AR44855 NIAMS-023 |
Study First Received: | November 3, 1999 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00000400 |
Health Authority: | United States: Food and Drug Administration |
Osteoporosis Bone formation Bone resorption Parathyroid hormone (PTH) Postmenopause |
Musculoskeletal Diseases Bone Resorption Teriparatide Alendronate |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |