Can Parathyroid Hormone Injections Reverse Glucocorticoid-induced Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00004993
First received: March 17, 2000
Last updated: March 1, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Osteoporosis
Drug: Parathyroid hormone (hPTH 1-34)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Can PTH Reverse Glucocorticoid-induced Osteoporosis

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date: August 1999
Estimated Study Completion Date: August 2001
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00004993

Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
Investigators
Study Director: Qaiser Rehman, M.D. University of California at San Francisco
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004993     History of Changes
Other Study ID Numbers: LANENE (completed), DK46661
Study First Received: March 17, 2000
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

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:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014