Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women

NCT ID: NCT00086619

Last Updated: 2013-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2009-12-31

Brief 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.

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.

Conditions

Postmenopausal Osteoporosis; Osteoporosis

Keywords

Osteoporosis; Parathyroid hormone; Teriparatide; Bone formation; Bone resorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

constant dose

Participants will receive synthetic human parathyroid hormone fragment 1-34 (hPTH 1-34) once-daily in a constant dose of 30 mcg/day.

Group Type: EXPERIMENTAL

synthetic hPTH 1-34

Intervention Type: DRUG

Either daily treatment with self-injected hPTH 1-34 or ascending dose treatment at 6-month intervals of hPTH 1-34

ascending dose

Participants will receive synthetic human parathyroid hormone fragment 1-34 (hPTH 1-34) once-daily in a dose that ascends at 6 month intervals (20-30-40 mcg/day).

Group Type: EXPERIMENTAL

synthetic hPTH 1-34

Intervention Type: DRUG

Either daily treatment with self-injected hPTH 1-34 or ascending dose treatment at 6-month intervals of hPTH 1-34

Interventions

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

Intervention Type: DRUG

Other Intervention Names

synthetic human parathyroid hormone 1-34

Eligibility 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

• Minimum Eligible Age: 46 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Robert M. Neer, MD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert M. Neer, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Joel S. Finkelstein, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Yu EW, Neer RM, Lee H, Wyland JJ, de la Paz AV, Davis MC, Okazaki M, Finkelstein JS. Time-dependent changes in skeletal response to teriparatide: escalating vs. constant dose teriparatide (PTH 1-34) in osteoporotic women. Bone. 2011 Apr 1;48(4):713-9. doi: 10.1016/j.bone.2010.11.012. Epub 2010 Nov 24.

Reference Type: RESULT

PMID: 21111078 (View on PubMed)

Other Identifiers

1P50AR044855

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAMS-123

Identifier Type: -

Identifier Source: org_study_id