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CompletedNCT00632216ROSPA-CTxUpdated Mar 11, 2008

A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis

A Phase 4 interventional study of Risedronate Sodium in Osteoporosis, Postmenopausal, sponsored by Sanofi. Completed. Open to female participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-03-11.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
464
Allocation
Non-randomized
Ages
55 Years to 70 Years
Sex
Female
01

Study summary

The study in the labeled and real conditions of prescription of Actonel will investigate the satisfaction of patients with its new formulation: 35 mg Once A Week. The study will also measure response rates in CTX (the C-telopeptide of type I collagen) at baseline and after 12 weeks of treatment with risedronate 35 mg Once A Week.

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 464 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 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Postmenopausal outpatients women > 55 and \< 70 years who have a clinical presentation appropriate for treatment of established osteoporosis based on the investigator's clinical judgment (a T-score for BMD (DEXA) of lumbar spine or femoral neck less than or equal to - 2.5 from an assessment performed at screening or within 12 months prior to the screening visit or evidence of previous vertebral fracture).

Exclusion criteria

Exclusion Criteria:

  • History of Cancer: Basal Cell or Squamous Cell carcinoma-documented 6-month remission.
  • Diagnosis of hypocalcemia, hyperparathyroidism, 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
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
464 participants (actual)

Interventions

  • DrugRisedronate Sodium
06

What researchers measure

Primary outcomes

  1. To determine the satisfaction of subject with Actonel 35 mg

    Time frame: Once a Week in the treatment of postmenopausal osteoporosis

Secondary outcomes

  1. To measure response rates in CTX with Actonel 35 mg

    Time frame: Once A Week

07

Study locations

No study locations are listed for this record.

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
NCT00632216
Lead sponsor
Sanofi
First posted
Mar 10, 2008
Start date
May 2004
Completion
May 2006
Last update
Mar 11, 2008

Study contacts

YEU Wang
study director · Sanofi

Oversight

Data monitoring committee
No
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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