Alendronate and/or Parathyroid Hormone for Osteoporosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bone Formation-Resorption Coupling and Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Human parathyroid hormone [hPTH-(1-34)]
* Drug: alendronate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTH<br>Human parathyroid hormone [hPTH-(1-34)] | Drug: Human parathyroid hormone [hPTH-(1-34)]<br>* 37 mcg once daily by self-administered sc injection<br>* Other names: teriparatide;|
| Active Comparator: ALN<br>Alendronate | Drug: alendronate<br>* 70 mg/week by oral route<br>* Other names: Fosamax;|
| Experimental: PTH+ALN<br>Human parathyroid hormone [hPTH-(1-34)] plus alendronate | Drug: Human parathyroid hormone [hPTH-(1-34)]<br>* 37 mcg once daily by self-administered sc injection<br>* Other names: teriparatide;Drug: alendronate<br>* 70 mg/week by oral route<br>* Other names: Fosamax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in spine bone mineral density |  | study months 30 (phase A), 42 (phase B), 54 (phase C) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in hip bone mineral density |  | study months 30 (phase A), 42 (phase B), 54 (phase C) | 
| change in forearm 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 serum osteocalcin |  | study months 0-30 (phase A), 30-42 (phase B), 42-54 (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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Bone formation, Bone resorption, Parathyroid hormone (PTH), Postmenopause