Effects of Parathyroid Hormone in Men With Osteoporosis

Completed · Phase 3

Conditions studied: Osteoporosis

In brief

Alendronate is a drug that blocks or reduces bone loss, while parathyroid hormone (PTH) stimulates the formation of new bone. The purpose of this study is to compare the bone-building effects of PTH alone, alendronate alone, and both PTH and alendronate in men with osteoporosis over a two-and-a-half year period.

Key facts

Study ID

NCT00000427

Run by

Massachusetts General Hospital

People needed

81

Starts

1999-09-01

Expected to finish

2005-10-01

Last updated by the study team

2013-12-09

Who can join

Age: 46 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Bone density of the spine or femoral neck two standard deviations below the mean of young adult men
• Normal renal and liver function tests, normal serum testosterone level, normal vitamin D and PTH levels

You may not qualify if…

• Significant cardiac, renal, hepatic, or malignant disease.
• Disorders (e.g., Paget's disease, hyperthyroidism, hyperparathyroidism) or drugs (e.g., steroids, anticonvulsants, lithium, bisphosphonates, calcitonin, fluoride) known to affect bone metabolism
• Active peptic ulcer disease or severe reflux

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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