Can Parathyroid Hormone Injections Reverse Glucocorticoid-induced Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004993
Recruitment Status : Completed
First Posted : March 20, 2000
Last Update Posted : March 2, 2010
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Parathyroid hormone (hPTH 1-34) Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Can PTH Reverse Glucocorticoid-induced Osteoporosis
Study Start Date : August 1999
Study Completion Date : August 2001

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004993

United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Director: Qaiser Rehman, M.D. University of California at San Francisco

Publications: Identifier: NCT00004993     History of Changes
Other Study ID Numbers: LANENE (completed)
First Posted: March 20, 2000    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: March 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Parathyroid hormone (1-34)
Glucocorticoid-induced osteoporosis
Postmenopausal women
osteoporotic fractures

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs