Status:

COMPLETED

Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover

Lead Sponsor:

Warner Chilcott

Conditions:

Postmenopausal Women With Osteoporosis

Eligibility:

FEMALE

Up to 85 years

Phase:

PHASE3

Brief Summary

The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.

Eligibility Criteria

Inclusion

  • Post-menopausal women who sequentially completed studies RVE009093, RVE1996077, RVE1998080

Exclusion

  • Less than 60% compliant between drug start and month 21
  • Using bisphosphonates, glucocorticoids, anabolic steroids, vitamin D supplements, calcitrol, estrogen or estrogen-related drugs, progestogen, depot injection \>10,000 IU vitamin D, investigational drug

Key Trial Info

Start Date :

October 1 2001

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2003

Estimated Enrollment :

61 Patients enrolled

Trial Details

Trial ID

NCT01249261

Start Date

October 1 2001

End Date

May 1 2003

Last Update

November 2 2011

Active Locations (13)

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Page 1 of 4 (13 locations)

1

Investigational Site

Concord, New South Wales, Australia, 2139

2

Investigational Site

Parkville, Victoria, Australia, 3052

3

Investigational Site

De Pintelaan 185, Gent, Belgium, B-9000

4

Investigational Site

Hvidovre, Denmark, Denmark, DK-2650