Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy (ACTIVATE)

A Randomized Multicenter Parallel Group Study to Determine if Knowledge of Baseline Vertebral Fracture Prevalence (as Determined by Hologic IVA) and Bone Turnover Marker Determinations Improves Persistence With Actonel 5mg Daily Therapy in Subjects Receiving Chronic Glucocorticoid Therapy

To evaluate the effect of subject knowledge of their disease status on persistence in subjects receiving Actonel 5 mg daily over a 12-month period for the prevention and treatment of GIO.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Actonel

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with a variety of rheumatologic, pulmonary, and skin conditions.
• Subjects were to be on oral glucocorticoids with a mean daily dose of greater than or equal to 5.0 mg prednisone (or its equivalent) and were expected (although not required) to remain on a daily dose of greater than or equal to 5.0 mg prednisone (or its equivalent) for 12 months after the study started.
• Women must have been at least one year post-menopausal or surgically sterile.
• Subjects must have had evaluable BMD site at the lumbar spine (LS) and proximal femur.

Exclusion Criteria:

• Subject's unwillingness to take Vitamin D, calcium supplements or study medication
• A history of cancer: any 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 if the subject has been in remission for at least 6 months prior to enrollment.
• A history of hyperparathyroidism, hyperthyroidism or osteomalacia or other metabolic bone disease within one year prior to enrollment
• History of alcohol or drug dependence within one year of enrollment
• A history of using any of the following medications within 6 months of starting study drug: Estrogen or estrogen-related drugs (tamoxifen, raloxifene, tibolone); low dose vaginal estrogen (estradiol < 0.2 mg/day, estropipate < 1.5 mg/day) will be allowed,Anabolic steroids,Parathyroid hormone
• A history of using any of the following medications within 1 month of starting study drugor for more than 1 month within 6 months prior to study entry: Calcitonin,Vitamin D supplements (>1000 IU per day),Calcitriol (>1.5mcg/week)
• A history of using any of the following medications within 6 months of starting study drug or for more than 14 days within 1 year prior to study entry: Any bisphosphonate,Fluoride (> 10 mg per day),Estrogen implant,Deflazacort
• Have received a depot injection of > 10,000 IU Vitamin D in the past 12 months
• Have a documented history of an abnormal or allergic reaction to bisphosphonates
• History of recurrent nephrolithiasis or a history of one episode of nephrolithiasis within 5years of study entry
• Severe renal impairment (creatinine clearance of <30 mL/min)
• Subjects on steroid therapy for transplantation
• Subjects on oral glucocorticoids for >8 weeks but <6 months at screening
• History of hypersensitivity to the investigational product or to drugs with similar chemical structures
• Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine whether subject knowledge of baseline vertebral fracture prevalence and awareness of results of bone turnover marker (BTM)determinations would result in an increase in persistence with Actonel 5 mg daily therapy	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate relationship between prevalence of vertebral fractures and duration of prior steroid therapy, amount of prior steroid therapy, and diagnosis of disease for which steroids were used	12 months
To evaluate the correlation between baseline vertebral fracture prevalence and subject persistence with Actonel 5 mg daily	12 months
Evaluate influence of Actonel 5 mg on BTM determinations and bone mineral density(BMD) at study finish relative to baseline	12 months

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: February 5, 2008
• First Submitted That Met QC Criteria: February 14, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Estimate): February 21, 2008
• Last Update Submitted That Met QC Criteria: February 20, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Spinal Injuries; Back Injuries; Osteoporosis; Spinal Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Risedronic Acid
• Other Study ID Numbers: HMR4003B_4027