Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Hormones; Parathyroid Hormone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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