Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00616694

Purpose

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	Intervention	Phase
Osteoporosis	Drug: Actonel	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Fractures Osteoporosis

Drug Information available for: Risedronic acid Risedronate sodium

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To evaluate the correlation between baseline vertebral fracture prevalence and subject persistence with Actonel 5 mg daily [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Evaluate influence of Actonel 5 mg on BTM determinations and bone mineral density(BMD) at study finish relative to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	248
Study Start Date:	July 2002
Study Completion Date:	December 2004

Intervention Details:

Actonel 5 mg orally once daily (OD), calcium 500 mg + vitamin D 200 units twice daily (BID)

Other Name: Risedronate Sodium

Eligibility

Ages Eligible for Study:	30 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616694

Locations

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

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Phyllis Diener

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00616694 History of Changes
Other Study ID Numbers:	HMR4003B_4027
Study First Received:	February 5, 2008
Last Updated:	February 20, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Osteoporosis
Spinal Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone
Glucocorticoids
Risedronic acid

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012