Can Parathyroid Hormone Injections Reverse Glucocorticoid-induced Osteoporosis

NCT ID: NCT00004993

Last Updated: 2010-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-08-31
• Study Completion Date: 2001-08-31

Brief Summary

Glucocorticoids are potent anti-inflammatory and immunosuppressive agents. However, prolonged use of these potent agents results in severe bone loss and osteoporotic fractures. Parathyroid hormone (1-34), when given as a daily injection has been found to dramatically increase bone mass in osteoporotic animals and postmenopausal women. The purpose of this study is to determine whether 2 years of daily PTH (1-34) injections will increase bone mass and reduce the development of new fractures. In addition, we will follow the study subjects for 2 more years to determine which type of anti-resorptive agent is required to maintain the newly formed bone.

We are enrolling postmenopausal women that are on chronic corticosteroid therapy (prednisone etc.) and have bone loss (osteopenia by DXA) to be a part of this four-year-long study. The patients will receive two-year therapy with either PTH (1-34) or placebo, and for the second part of the study subjects receive either estrogen and placebo or alendronate and placebo. We will measure bone gain by standard bone densitometry, special x-rays of the spine and hip, and serum and urine bone markers.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Parathyroid hormone (hPTH 1-34)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Postmenopausal women on glucocorticoids (prednisone 5mg/d or greater
• Osteopenia by T score of hip or lumbar spine of -2.0
• All study subjects must be on a stable dose of estrogen/progesterone or raloxifene
• Ambulatory and able to come to the clinical center 9 times over 2 years
• Willing to sign an informed consent

Exclusion Criteria

• Generalized disease of the bone (other than glucocorticoid-induced osteoporosis), including hyperparathyroidism, hyperthyroidism, Paget's disease)
• Diseases that affect bone metabolism (e.g. alcoholism, inflammatory bowel disease, malabsorption, renal disease (Cr2) or liver disease (transaminase level 2 times limit of normal)
• Within the past 1 year, regular use of medications that are known to affect bone metabolism (e.g. anabolic steroids, anticoagulants, anticonvulsants, pharmacologic doses of vitamin D and vitamin A supplements).
• History of drug abuse
• Senile dementia, paraplegia and/or quadriplegia
• Unstable rheumatic disease with clinically significant renal or central nervous system involvement.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Principal Investigators

Qaiser Rehman, M.D.

Role: STUDY_DIRECTOR

University of California at San Francisco

Locations

San Francisco General Hospital

San Francisco, California, United States

Countries

United States

References

Lane NE, Sanchez S, Modin GW, Genant HK, Pierini E, Arnaud CD. Parathyroid hormone treatment can reverse corticosteroid-induced osteoporosis. Results of a randomized controlled clinical trial. J Clin Invest. 1998 Oct 15;102(8):1627-33. doi: 10.1172/JCI3914.

Reference Type: BACKGROUND

PMID: 9788977 (View on PubMed)

Other Identifiers

DK46661

Identifier Type: -

Identifier Source: secondary_id

LANENE (completed)

Identifier Type: -

Identifier Source: org_study_id