NCT00729651

Brief Summary

To demonstrate the efficacy/safety of Fosamax Plus D

Trial Health

100
On Track

Trial Health Score

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

Enrollment
343

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_4

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

March 20, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2009

Completed
12 months until next milestone

Results Posted

Study results publicly available

April 2, 2010

Completed
Last Updated

April 23, 2024

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

August 5, 2008

Results QC Date

February 5, 2010

Last Update Submit

April 17, 2024

Conditions

Osteoporosis Postmenopausal

Outcome Measures

Primary Outcomes (1)

  • Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment

    16 weeks

Secondary Outcomes (1)

  • Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment

    Baseline and 16 weeks

Study Arms (2)

1

EXPERIMENTAL

Alendronate sodium/Cholecalciferol

Drug: alendronate sodium (+) cholecalciferolDietary Supplement: Comparator: Calcium

2

ACTIVE COMPARATOR

Alendronate sodium

Drug: Comparator: Alendronate sodium (Fosamax)Dietary Supplement: Comparator: Calcium

Interventions

alendronate sodium (+) cholecalciferolDRUG

Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks

Also known as: Fosamax Plus D
1
Comparator: Alendronate sodium (Fosamax)DRUG

Alendronate sodium; tablet, once weekly, for 16 weeks

2
Comparator: CalciumDIETARY_SUPPLEMENT

500 mg oral tablet calcium once daily, for 16 weeks

12

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
  • Patient has been diagnosed with osteoporosis
  • Patient has been postmenopausal for more than 6 months
  • Patient has no contraindication to taking oral bisphosphonates
  • Patient is eligible for dual energy x-ray absorptiometry in spine or hip

You may not qualify if:

  • Patients with esophageal dysfunction
  • Patients who can not sit or stand at least 30 minutes
  • Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial
  • Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism
  • Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kim KJ, Min YK, Koh JM, Chung YS, Kim KM, Byun DW, Kim IJ, Kim M, Kim SS, Min KW, Han KO, Park HM, Shin CS, Choi SH, Park JS, Chung DJ, Mok JO, Baek HS, Moon SH, Kim YS, Lim SK; VALUE study group. Efficacy and safety of weekly alendronate plus vitamin D(3) 5600 IU versus weekly alendronate alone in Korean osteoporotic women: 16-week randomized trial. Yonsei Med J. 2014 May;55(3):715-24. doi: 10.3349/ymj.2014.55.3.715. Epub 2014 Apr 1.

    PMID: 24719139RESULT

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

AlendronateCholecalciferolFumigant 93

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 7, 2008

Study Start

March 20, 2008

Primary Completion

April 10, 2009

Study Completion

April 10, 2009

Last Updated

April 23, 2024

Results First Posted

April 2, 2010

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share