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CompletedNCT00453492Updated Mar 11, 2008

Risedronate Sodium in Post Menopausal Osteoporosis

A Phase 4 interventional study of risedronate sodium in Osteoporosis, Postmenopausal, sponsored by Sanofi. Completed at 1 site in Turkey. Open to female participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-03-11.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
246
Allocation
Randomized
Ages
55 Years to 80 Years
Sex
Female
01

Study summary

The primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women.

The secondary objectives are to measure compliance (50 % drug taken), and persistence, [and urinary NTx (N-telopeptides) (optional)].

02

Conditions studied

  • Osteoporosis, Postmenopausal
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 246 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Five years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria.
  • Subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (≥ 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. During the study, these drugs are not permitted other than the study medication, Actonel.
  • Other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication, they may be given at the discretion of the Investigator.

Exclusion criteria

Exclusion criteria :

  • Had a history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion criteria if the subject has been in remission for at least 6 months prior to enrollment.
  • Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
246 participants

Interventions

  • Drugrisedronate sodium
06

What researchers measure

Primary outcomes

  1. Measurement of subject satisfaction using a questionnaire at 12 and 24 weeks and a tablets counts at 12 and 24 weeks.

  2. Optional: the effects of Actonel on bone resorption will be assessed by a change of urinary NTx, after 12 and 24 weeks of treatment as compared to baseline.

07

Study locations

1 site
  • Sanofi-Aventis
    Istanbul, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00453492
Lead sponsor
Sanofi
Collaborators
Procter and Gamble
First posted
Mar 29, 2007
Start date
Jan 2004
Last update
Mar 11, 2008

Study contacts

Edibe Taylan
study director · Sanofi-aventis, Turkey
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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