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

Tracking Information

First Received Date ^ICMJE

July 7, 2004

Last Updated Date

May 8, 2009

Start Date ^ICMJE

May 2004

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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])

Change History

Complete list of historical versions of study NCT00086619 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Bone density (changes in bone mineral density of the spine, femur, radius, and ulna, and changes in total body bone mineral)

Descriptive Information

Brief Title ^ICMJE

Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women

Official Title ^ICMJE

Evaluation of Factors That Affect Skeletal Responses to PTH

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Postmenopausal Osteoporosis
Osteoporosis

Intervention ^ICMJE

Drug: synthetic hPTH 1-34

Study Arms / Comparison Groups

Experimental: Participants will receive constant dose synthetic hPTH 1-34 (30 mcg/day).
Experimental: Participants will receive ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

46 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00086619

Responsible Party

Robert M. Neer, MD, Masachusetts General Hospital, Fruit St., Boston, MA 02114

Study ID Numbers ^ICMJE

NIAMS-123

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Robert M. Neer, MD	Massachusetts General Hospital
Principal Investigator:	Joel S. Finkelstein, MD	Massachusetts General Hospital

Information Provided By

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

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP