NCT00616694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
Last Updated

February 21, 2008

Status Verified

February 1, 2008

First QC Date

February 5, 2008

Last Update Submit

February 20, 2008

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (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

    12 months

Secondary Outcomes (3)

  • 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

Interventions

ActonelDRUG

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

Also known as: Risedronate Sodium

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subject's unwillingness to take Vitamin D, calcium supplements or study medication
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Phyllis Diener

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 15, 2008

Study Start

July 1, 2002

Study Completion

December 1, 2004

Last Updated

February 21, 2008

Record last verified: 2008-02

Locations

US(1)