NCT00004993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 1999

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2000

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
Last Updated

March 2, 2010

Status Verified

March 1, 2010

First QC Date

March 17, 2000

Last Update Submit

March 1, 2010

Conditions

Osteoporosis

Keywords

Parathyroid hormone (1-34)Glucocorticoid-induced osteoporosisPostmenopausal womenosteoporotic fractures

Interventions

Parathyroid hormone (hPTH 1-34)DRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (1)

  • 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.

    PMID: 9788977BACKGROUND

MeSH Terms

Conditions

OsteoporosisOsteoporotic Fractures

Interventions

Parathyroid HormoneTeriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Qaiser Rehman, M.D.

    University of California at San Francisco

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 17, 2000

First Posted

March 20, 2000

Study Start

August 1, 1999

Study Completion

August 1, 2001

Last Updated

March 2, 2010

Record last verified: 2010-03

Locations

US(1)