NCT00092014

Brief Summary

This study is to evaluate and compare the effects of Alendronate and Risedronate to treat women with postmenopausal osteoporosis. The primary hypothesis for this study is that in postmenopausal women with osteoporosis, treatment with oral alendronate 70 mg once weekly will produce a mean percent increase from baseline in hip trochanter bone mineral density (BMD) at 12 and 24 months which is greater than that observed with oral risedronate 35 mg once weekly.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,053

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2002

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2004

Completed
Last Updated

August 14, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

September 21, 2004

Last Update Submit

August 12, 2024

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (2)

  • Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months

    Baseline and 12 months

  • Mean percent change from baseline in hip trochanter BMD at 24 months

    Baseline and 24 months

Secondary Outcomes (8)

  • Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months

    Baseline and 12 months

  • Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months

    Baseline and 24 months

  • Change from baseline in biochemical markers of bone turnover at 12 months

    Baseline and 12 months

  • Change from baseline in biochemical markers of bone turnover at 24 months

    Baseline and 24 months

  • Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months

    12 months

  • +3 more secondary outcomes

Study Arms (2)

Alendronate 70 mg

EXPERIMENTAL

Alendronate sodium, 70 mg, orally once weekly for up to 24 months

Drug: AlendronateDietary Supplement: Elemental CalciumDietary Supplement: Vitamin DDrug: Risendronate placebo

Risendronate 35 mg

ACTIVE COMPARATOR

Risendronate, 35 mg, orally once weekly for up to 24 months

Drug: Risedronate 35 mgDietary Supplement: Elemental CalciumDietary Supplement: Vitamin DDrug: Alendronate placebo

Interventions

AlendronateDRUG

Alendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Also known as: MK-0217, FOSAMAX®
Alendronate 70 mg
Risedronate 35 mgDRUG

Risendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Also known as: Actonel®, Atelvia®
Risendronate 35 mg
Elemental CalciumDIETARY_SUPPLEMENT

Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.

Alendronate 70 mgRisendronate 35 mg
Vitamin DDIETARY_SUPPLEMENT

Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.

Alendronate 70 mgRisendronate 35 mg
Risendronate placeboDRUG

Risendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Alendronate 70 mg
Alendronate placeboDRUG

Alendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Risendronate 35 mg

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with postmenopausal osteoporosis

You may not qualify if:

  • Bilateral hip replacements
  • Esophageal abnormalities
  • Metabolic bone disease (example - Vitamin D deficiency)
  • Medications that would affect the breakdown or build-up of bone turnover

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Rosen CJ, Hochberg MC, Bonnick SL, McClung M, Miller P, Broy S, Kagan R, Chen E, Petruschke RA, Thompson DE, de Papp AE; Fosamax Actonel Comparison Trial Investigators. Treatment with once-weekly alendronate 70 mg compared with once-weekly risedronate 35 mg in women with postmenopausal osteoporosis: a randomized double-blind study. J Bone Miner Res. 2005 Jan;20(1):141-51. doi: 10.1359/JBMR.040920. Epub 2004 Sep 29.

    PMID: 15619680BACKGROUND

  • Sebba AI, Bonnick SL, Kagan R, Thompson DE, Skalky CS, Chen E, de Papp AE; Fosamax Actonel Comparison Trial investigators. Response to therapy with once-weekly alendronate 70 mg compared to once-weekly risedronate 35 mg in the treatment of postmenopausal osteoporosis. Curr Med Res Opin. 2004 Dec;20(12):2031-41. doi: 10.1185/030079904x16768.

    PMID: 15706659BACKGROUND

  • Bonnick S, Saag KG, Kiel DP, McClung M, Hochberg M, Burnett SM, Sebba A, Kagan R, Chen E, Thompson DE, de Papp AE. Comparison of weekly treatment of postmenopausal osteoporosis with alendronate versus risedronate over two years. J Clin Endocrinol Metab. 2006 Jul;91(7):2631-7. doi: 10.1210/jc.2005-2602. Epub 2006 Apr 24.

    PMID: 16636120BACKGROUND

  • Burnett-Bowie SM, Saag K, Sebba A, de Papp AE, Chen E, Rosenberg E, Greenspan SL. Prediction of changes in bone mineral density in postmenopausal women treated with once-weekly bisphosphonates. J Clin Endocrinol Metab. 2009 Apr;94(4):1097-103. doi: 10.1210/jc.2008-1122. Epub 2009 Jan 13.

    PMID: 19141590BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

AlendronateRisedronic AcidCalciumVitamin D

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2004

First Posted

September 24, 2004

Study Start

September 1, 2002

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

August 14, 2024

Record last verified: 2024-04