Effect of Stopping Risedronate After Long Term Treatment on Bone Turnover

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Women With Osteoporosis

Treatments: Drug: Risedronate; Drug: Placebo/Risedronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01249261

2001079

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: Female

Ages: Under 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

61 participants in 2 patient groups, including a placebo group

Placebo/Risedronate

Placebo Comparator group

Description:

Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8

Treatment:

Drug: Placebo/Risedronate

Risedronate

Active Comparator group

Description:

Risedronate 5mg years 1-7, no drug year 8

Treatment:

Drug: Risedronate