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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Osteoporosis

Treatments

Drug: Actonel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00616694

HMR4003B_4027

Details and patient eligibility

About

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.

Enrollment

248 patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

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