Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD

Active-controlled, Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly in Postmenopausal Women With Low Bone Mineral Density

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00577837

Enrollment

370

Registered

2007-12-20

Start date

2004-04-30

Completion date

2005-06-30

Last updated

2013-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal

Brief summary

A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.

Interventions

DRUGrisedronate

tablet, 5 mg risedronate daily for 6 months

DRUGexperimental

tablet, 200 mg risedronate monthly for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 85 Years

Healthy volunteers

Inclusion criteria

* be postmenopausal 5 years based on medical history; follicle stimulating hormone and estradiol will be evaluated for any patient less than 65 years of age, who has undergone hysterectomy without bilateral oophorectomy, to ensure the patient is postmenopausal

Exclusion criteria

* use of any of the following medications within 3 months of starting study drug or use of any of the following medications for more than 1 month at any time within 6 months prior to starting study drug: * oral or parenteral glucocorticoids (5 mg prednisone or equivalent per day) * anabolic steroids * estrogen, raloxifene or estrogen-related drugs, eg, tamoxifen, tibolone, (except for low dose vaginal creams, tablets or insertable estrogen ring * progestogen * calcitonin * vitamin D supplements (greater than 800 IU per day) * calcitriol, calcidiol, or alfacalcidol * any bisphosphonate * fluoride (10 mg per day) * strontium and other bone active agents * parathyroid hormone * heparin, warfarin, and other similar anticoagulants

Design outcomes

Primary

Measure	Time frame
Evaluate the safety of 3 once-monthly dosing regimens of risedronate, 100 mg, 150 mg and 200 mg, compared to a once-daily dosing regimen, 5 mg, as assessed by clinical laboratory values and adverse event (AE) profiles	6 months

Secondary

Measure	Time frame
Evaluate the efficacy of 3 once-monthly dosing regimens or risedronate compared to a once-daily dosing regimen and to evaluate the PK/PD of monthly and daily dose regimens	6 months

Countries

Canada, Croatia, Netherlands, Poland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026