Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women - Full Text View

Sponsored by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00086619

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 II

MedlinePlus related topics: Osteoporosis

Drug Information available for: Parathyroid Teriparatide Teriparatide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Evaluation of Factors That Affect Skeletal Responses to PTH

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

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]) [ Time Frame: total interval on allocated Rx ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Experimental 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

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086619

Locations

United States, Massachusetts
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

More Information

Responsible Party:	Masachusetts General Hospital, Fruit St., Boston, MA 02114 ( Robert M. Neer, MD )
Study ID Numbers:	NIAMS-123
Study First Received:	July 7, 2004
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00086619
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

Study placed in the following topic categories:

Musculoskeletal Diseases
Bone Resorption
Teriparatide
Osteoporosis, Postmenopausal

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on January 15, 2009