Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women

Completed · Phase 2

Conditions studied: Postmenopausal Osteoporosis, Osteoporosis

In brief

Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment increases bone formation less and less over time. This study will test whether increasing the daily dose of PTH sustains its ability to improve bone formation, and optional sub-studies will test several potential reasons why PTH's effects on bone formation decline over time.

Key facts

Study ID

NCT00086619

Run by

Massachusetts General Hospital

People needed

80

Starts

2004-05-01

Expected to finish

2009-12-01

Last updated by the study team

2013-10-30

Who can join

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

You may qualify if…

• Three or more years after menopause
• Bone mineral density T-score < or = -2.0 by dual-energy x-ray absorptiometry (DXA) of vertebrae or femoral neck, or by quantitative computerized tomography (QCT) of vertebral body trabeculae

You may not qualify if…

• Cannot walk without assistance
• Significant heart, kidney, liver, or malignant disease
• Current alcohol abuse
• Major psychiatric disorders
• Other current or past disorders known to affect bone
• Use of medications known to affect bone for > 7 days in the past 12 months
• Use of bisphosphonates or fluoride
• Abnormal blood calcium, PTH, 25-hydroxy vitamin D, creatinine, liver function tests, or complete blood count
• Elevated calcium levels in 24-hour urine collection

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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