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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616694
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : February 21, 2008
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Actonel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2002
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Actonel
    Actonel 5 mg orally once daily (OD), calcium 500 mg + vitamin D 200 units twice daily (BID)
    Other Name: Risedronate Sodium

Primary Outcome Measures :
  1. 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 [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 12 months ]
  2. To evaluate the correlation between baseline vertebral fracture prevalence and subject persistence with Actonel 5 mg daily [ Time Frame: 12 months ]
  3. Evaluate influence of Actonel 5 mg on BTM determinations and bone mineral density(BMD) at study finish relative to baseline [ Time Frame: 12 months ]

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00616694

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United States, New Jersey
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
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Study Director: Phyllis Diener Sanofi
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Responsible Party: Study Director, sanofi-aventis Identifier: NCT00616694    
Other Study ID Numbers: HMR4003B_4027
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: February 21, 2008
Last Verified: February 2008
Additional relevant MeSH terms:
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Spinal Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone
Risedronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents