Osteoporosis
Conditions
Keywords
Osteoporosis, Bone formation, Bone resorption, Parathyroid hormone (PTH), Postmenopause
Brief summary
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.
Detailed description
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.
Interventions
DRUGHuman parathyroid hormone [hPTH-(1-34)]
37 mcg once daily by self-administered sc injection
DRUGalendronate
70 mg/week by oral route
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Lumbar spine or hip BMD T-score less than or equal to minus 2.0 * Postmenopausal at least 5 years * Fully ambulatory * Able to give informed consent
Exclusion criteria
* No concurrent illnesses that cause bone loss * No recent drug treatment for osteoporosis * No recent fracture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in spine bone mineral density | study months 30 (phase A), 42 (phase B), 54 (phase C) |
Secondary
| Measure | Time frame |
|---|---|
| change in hip bone mineral density | study months 30 (phase A), 42 (phase B), 54 (phase C) |
| change in total body bone mineral | study months 30 (phase A), 42 (phase B), 54 (phase C) |
| change in femoral shaft bone mineral density | study months 30 (phase A), 42 (phase B), 54 (phase C) |
| change in serum PINP | study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) |
| change in forearm bone mineral density | study months 30 (phase A), 42 (phase B), 54 (phase C) |
| change in serum NTX | study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) |
| incidence of hypercalcemia | study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) |
| incidence of hypercalciuria | study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) |
| incidence of symptoms | study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) |
| change in serum osteocalcin | study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) |
Countries
United States
Outcome results
None listed