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IMPACT Study (Improving Measurements of Persistence on "ACtonel" Treatment)

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Osteoporosis

Treatments

Drug: risedronate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00268632
HMR4003B_4001

Details and patient eligibility

About

The primary objective of this study is to assess the impact of physician's reinforcement using bone marker data on the subject's compliance (at least 50% drug taken) and persistence on treatment after one year in postmenopausal osteoporotic women.

Sex

Female

Ages

65 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ambulatory women,
  • Caucasian, Oriental or Multiracial
  • not previously diagnosed for osteoporosis.

Exclusion criteria

  • Females of black descent and for the US african american are excluded because of the very low incidence of postmenopausal osteoporosis
  • and having used oral or parenteral glucocorticoids (>= 5 mg prednisone or equivalent per day) within 3 months of starting study drug or for more than one month within six months prior to study entry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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