NCT01552122

Brief Summary

This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2012

Typical duration for phase_3

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

March 9, 2012

Last Update Submit

August 26, 2015

Conditions

OsteoporosisPostmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck

    Baseline and Month 24

Secondary Outcomes (1)

  • Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter

    Baseline and Month 24

Study Arms (2)

Odanacatib

EXPERIMENTAL
Drug: OdanacatibDietary Supplement: Cholecalciferol (Vitamin D3)Dietary Supplement: Calcium carbonateOther: Placebo (alendronate)

Alendronate

ACTIVE COMPARATOR
Drug: AlendronateOther: Placebo (odanacatib)Dietary Supplement: Cholecalciferol (Vitamin D3)Dietary Supplement: Calcium carbonate

Interventions

OdanacatibDRUG

Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months

Also known as: MK-0822
Odanacatib
AlendronateDRUG

Alendronate 70 mg compressed tablets will be administered orally, once-a-week, for 24 months; and a reduced dose of 35 mg will be administered in the same fashion to a subset of women, Japanese participants only, for the same 24-month duration.

Also known as: Alendronate Sodium, Fosamax
Alendronate
Placebo (odanacatib)OTHER

One compressed tablet administered orally, once-a-week, for 24 months.

Alendronate
Cholecalciferol (Vitamin D3)DIETARY_SUPPLEMENT

Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.

AlendronateOdanacatib
Calcium carbonateDIETARY_SUPPLEMENT

Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.

AlendronateOdanacatib
Placebo (alendronate)OTHER

One compressed tablet administered orally, once-a-week, for 24 months.

Odanacatib

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In good general health, and postmenopausal for at least 5 years or more
  • Diagnosed with postmenopausal osteoporosis
  • Currently taking alendronate for at least 3 years or more for the treatment of osteoporosis
  • One hip free of orthopedic hardware (ie, total hip device, hip pin); anatomy is suitable to undergo a dual-emission X-ray absorptiometry (DXA) scan (ie, bone mineral density scan)
  • Agrees to not to use any other medications for the treatment of osteoporosis except those provided to the participant during the study

You may not qualify if:

  • Evidence of metabolic bone disorder
  • History of malignancy (cancer) for 5 years or less
  • Active thyroid disease that cannot be managed with medication
  • Severe renal insufficiency (kidney disease), myocardial infarction, unstable angina, stroke or revascularization, untreated malabsorption syndrome, and/or osteonecrosis of the jaw, or anticipates undergoing a major dental procedure (e.g. dental extraction or implantation)
  • Use, misuse, abuse, and/or addiction of illicit drugs and/or recent history
  • (within the last year) of drug or alcohol abuse or dependence
  • Use of estrogen with or without progestin and/or raloxifene (ie, Evista®) or tamoxifen (ie, Nolvadex®, Tamofen®)
  • Use of any oral bisphosphonate therapy other than alendronate; intravenous bisphosphonates (zoledronate, ibandronate, pamidronate); any form of calcitonin other than intranasal; anabolic steroids; and/or Strontium-containing products (ie, Osteovalin™)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoporosisOsteoporosis, Postmenopausal

Interventions

odanacatibAlendronateCholecalciferolCalcium Carbonate

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals
0

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

March 9, 2012

First Posted

March 13, 2012

Study Start

May 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 27, 2015

Record last verified: 2015-08