Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover

Postmenopausal Women With Osteoporosis Clinical Trial

Official title:

A 1-year, Risedronate-free, Multicenter, Outpatient, Phase IIIb Extension Study to Assess Bone Turnover Recovery in Women With Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, and RVE1998080 (no NCT Study Numbers)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249261
• Other study ID #: 2001079
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2010
• Last updated: October 27, 2011
• Start date: October 2001
• Est. completion date: May 2003

Study information

• Verified date: October 2011
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Postmenopausal Women With Osteoporosis

Intervention

Drug:
• Risedronate
5 mg/day
• Placebo/Risedronate
placebo years 1-5 followed by 5 mg risedronate years 6 & 7 and no drug year 8

Locations

Country	Name	City	State
Australia	Investigational Site	Concord	New South Wales
Australia	Investigational Site	Parkville	Victoria
Belgium	Investigational Site	De Pintelaan 185	Gent
Denmark	Investigational Site	Hvidovre
Finland	Investigational Site	Oulu
Italy	Investigational Site	Siena
Poland	Investigational Site	Warsaw
Poland	Investigational Site	Warszawa
Poland	Investigational Site	Warszawa
Poland	Investigational Site	Warszawa
Spain	Investigational Site	Barcelona
Spain	Investigational Site	Madrid
Sweden	Investigational Site	Goteborg

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Countries where clinical trial is conducted

Australia,  Belgium,  Denmark,  Finland,  Italy,  Poland,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population	Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).	Baseline Core Study (Year 1) to Month 6 (Year 8)	No
Primary	Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population	Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).	Baseline Core Study (Year 1) to Month 12 (Year 8)	No
Primary	Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population	Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).	Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)	No
Primary	Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population	Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).	Baseline Core Study (Year 1) to Month 6 (Year 8)	No
Primary	Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population	Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).	Baseline Core Study (Year 1) to Month 12 (Year 8)	No
Primary	Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population	Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).	Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)	No
Primary	Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population	Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).	Baseline Core Study (Year 1) to Month 6 (Year 8)	No
Primary	Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population	Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).	Baseline Core Study (Year 1) to Month 12 (Year 8)	No
Primary	Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population	Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).	Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)	No
Primary	Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population	Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).	Baseline Core Study (Year 1) to Month 6 (Year 8)	No
Primary	Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population	Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).	Baseline Core Study (Year 1) to Month 12 (Year 8)	No
Primary	Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population	Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).	Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)	No