Alendronate and/or Parathyroid Hormone for Osteoporosis

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Drug: alendronate; Drug: Human parathyroid hormone [hPTH-(1-34)]

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00000400

P50 AR44855 NIAMS-023

P50AR044855 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 3 patient groups

PTH

Experimental group

Description:

Human parathyroid hormone \[hPTH-(1-34)\]

Treatment:

Drug: Human parathyroid hormone [hPTH-(1-34)]

ALN

Active Comparator group

Description:

Alendronate

Treatment:

Drug: alendronate

PTH+ALN

Experimental group

Description:

Human parathyroid hormone \[hPTH-(1-34)\] plus alendronate

Treatment:

Drug: Human parathyroid hormone [hPTH-(1-34)]

Drug: alendronate