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OpenTrials
Completed

NCT Number: NCT00632216

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

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.

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Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

55 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

risedronate sodium

Drug

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Multicenter and Prospective Study to Determine the Satisfaction With Actonel (Risedronate Sodium) 35mg Once a Week Using Biochemical Markers of Bone as a Control, in Postmenopausal Women With Osteoporosis

Acronym: ROSPA-CTx

Important dates

Study start
2004
Study completion
2006
First posted
Mar 10, 2008
Registry last updated
Mar 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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