Clinical trial NCT01249261: Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Women With Osteoporosis
Keywords: Postmenopausal Women
Osteoporosis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2010-11-29
Enrollment: 61
Sex: FEMALE
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population
timeFrame: Baseline Core Study (Year 1) to Month 6 (Year 8)
measure: Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population
timeFrame: Baseline Core Study (Year 1) to Month 12 (Year 8)
measure: Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
timeFrame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
measure: Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population
timeFrame: Baseline Core Study (Year 1) to Month 6 (Year 8)
measure: Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population
timeFrame: Baseline Core Study (Year 1) to Month 12 (Year 8)
measure: Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
timeFrame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
measure: Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population
timeFrame: Baseline Core Study (Year 1) to Month 6 (Year 8)
measure: Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population
timeFrame: Baseline Core Study (Year 1) to Month 12 (Year 8)
measure: Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
timeFrame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
measure: Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population
timeFrame: Baseline Core Study (Year 1) to Month 6 (Year 8)
measure: Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population
timeFrame: Baseline Core Study (Year 1) to Month 12 (Year 8)
measure: Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population
timeFrame: Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: Australia
facility: Investigational Site
state: New South Wales
city: Parkville
country: Australia
facility: Investigational Site
state: Victoria
city: De Pintelaan 185
country: Belgium
facility: Investigational Site
state: Gent
city: Hvidovre
country: Denmark
facility: Investigational Site
city: Oulu
country: Finland
facility: Investigational Site
city: Siena
country: Italy
facility: Investigational Site
city: Warsaw
country: Poland
facility: Investigational Site
city: Warszawa
country: Poland
facility: Investigational Site
city: Warszawa
country: Poland
facility: Investigational Site
city: Warszawa
country: Poland
facility: Investigational Site
city: Barcelona
country: Spain
facility: Investigational Site
city: Madrid
country: Spain
facility: Investigational Site
city: Goteborg
country: Sweden
facility: Investigational Site
Study officials:
affiliation: Warner Chilcott
name: Herman Ellman, MD
role: STUDY_DIRECTOR
References: