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.
Official Title
Evaluation of Factors That Affect Skeletal Responses to PTHa.
Conditions
- Postmenopausal Osteoporosis
- Osteoporosis
Study Type
Interventional
Study Design
Treatment, Randomised, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study.
Further Details
Primary Outcome Measures:
- Bone turnover (changes in serum and/or urine indices of bone formation and bone resorption, such as aminoterminal propeptide of type I collagen [PINP], osteocalcin, N-telopeptide cross-links [NTX])
Secondary Outcome Measures:
- Bone density (changes in bone mineral density of the spine, femur, radius, and ulna, and changes in total body bone mineral)
Study Start
May 2004
Eligibility & Criteria
- Ages Eligible for Study: 46 Years to 85 Years
- Genders Eligible for Study: Female
- Accepts Healthy Volunteers: No
- Three or more years after menopause
- Spine or femoral neck bone density T-score less than -2.0
Exclusion Criteria:
- Cannot walk without assistance
- Significant heart, kidney, liver, or malignant disease
- Current alcohol abuse
- Major psychiatric disorders
- Current disorders known to affect bone
- Use of medications known to affect bone for more than 7 days in the past 12 months
- Use of bisphosphonates or fluoride
- Abnormal blood calcium, creatinine, liver function tests, or complete blood count
- Elevated calcium levels in 24-hour urine test
Total Enrolment
80
Contact Details
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086619
Telephone:
+1-
617-726-2000
Locations
Massachusetts General Hospital
Boston, Massachusetts
United States, 02114
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator:
Robert M. Neer, MD
Massachusetts General Hospital
Principal Investigator:
Joel S. Finkelstein, MD
Massachusetts General Hospital
All content and media on the HealthEngine Blog is created and published online for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking it because of something you have read on this Website. If you think you may have a medical emergency, call your doctor, go to the nearest hospital emergency department, or call the emergency services immediately.
Related Articles
Need a health appointment?
Find and book a doctor, dentist, physio and more on Healthengine
Find a practitioner
