Back to resultsImpact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy (ACTIVATE)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Actonel
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
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.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
To evaluate the correlation between baseline vertebral fracture prevalence and subject persistence with Actonel 5 mg daily
Evaluate influence of Actonel 5 mg on BTM determinations and bone mineral density(BMD) at study finish relative to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00616694
Brief Title
Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy
Acronym
ACTIVATE
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 Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Actonel
Other Intervention Name(s)
Risedronate Sodium
Intervention Description
Actonel 5 mg orally once daily (OD), calcium 500 mg + vitamin D 200 units twice daily (BID)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
To evaluate the correlation between baseline vertebral fracture prevalence and subject persistence with Actonel 5 mg daily
Time Frame
12 months
Title
Evaluate influence of Actonel 5 mg on BTM determinations and bone mineral density(BMD) at study finish relative to baseline
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phyllis Diener
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy
We'll reach out to this number within 24 hrs