Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postmenopausal Osteoporosis Osteoporosis |
Drug: synthetic hPTH 1-34 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Factors That Affect Skeletal Responses to PTH |
- 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]) [ Time Frame: total interval on allocated Rx ] [ Designated as safety issue: No ]
- Bone density (changes in bone mineral density of the spine, femur, radius, and ulna, and changes in total body bone mineral) [ Time Frame: total interval on allocated Rx; and total interval observed ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive constant dose synthetic hPTH 1-34 (30 mcg/day).
|
Drug: synthetic hPTH 1-34
Either daily treatment with self-injected hPTH 1-34 or ascending dose treatment at 6-month intervals of hPTH 1-34
Other Name: synthetic human parathyroid hormone 1-34
|
|
Experimental: 2
Participants will receive ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
|
Drug: synthetic hPTH 1-34
Either daily treatment with self-injected hPTH 1-34 or ascending dose treatment at 6-month intervals of hPTH 1-34
Other Name: synthetic human parathyroid hormone 1-34
|
Detailed Description:
In women with postmenopausal osteoporosis, PTH increases bone mineral density more than anti-resorptive agents, and its use markedly reduces the incidence of new spine and non-spine fractures. Still, PTH is not a cure for osteoporosis in many patients because PTH-stimulated bone formation declines as PTH therapy continues. Biochemical analyses suggest that bone formation and resorption peak after 6 to 9 months of daily PTH therapy and then decline progressively.
The study will last 18 months. Blood, urine, and bone density tests will occur at screening. At the start of the study, participants will be randomly assigned to one of two PTH dose regimens. Patients will go to Massachusetts General Hospital at Months 0, 3, 6, 9, 12, 15, and 18 for blood and urine collection. In addition, bone density tests by DXA will be performed at Months 0, 6, 12, and 18, and by quantitative CT scans at Months 0 and 18. Approximately 6 weeks after any change in PTH dose, each participant's blood calcium will be checked 4 to 6 hours after that day's PTH injection, and her 24-hour urine calcium excretion will also be checked.
Participants may enroll in optional substudies that will test whether reduced skeletal responses to long-term treatment with PTH are accompanied by changes in its absorption and/or destruction and whether reduced skeletal responses to long-term treatment with PTH are accompanied by parallel reductions in kidney responses to PTH.
Eligibility| Ages Eligible for Study: | 46 Years to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Robert M. Neer, MD | Massachusetts General Hospital |
| Principal Investigator: | Joel S. Finkelstein, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Robert M. Neer, MD, Masachusetts General Hospital, Fruit St., Boston, MA 02114 |
| ClinicalTrials.gov Identifier: | NCT00086619 History of Changes |
| Other Study ID Numbers: | NIAMS-123 |
| Study First Received: | July 7, 2004 |
| Last Updated: | May 8, 2009 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
|
Osteoporosis Parathyroid hormone Teriparatide Bone formation Bone resorption |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013