NCT01544894

Brief Summary

The purpose of this study was to compare compliance and efficacy of raloxifene and strontium ranelate in a group of women with postmenopausal osteoporosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

2.1 years

First QC Date

January 18, 2012

Last Update Submit

August 31, 2012

Conditions

Postmenopausal OsteoporosisCompliance

Keywords

Postmenopausal osteoporosisComplianceBone mineral densityBonemarkers

Outcome Measures

Primary Outcomes (1)

  • Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis

    Primary Outcome measure: compliance. Assessment of compliance assessed two variables, the number of participants maintaining treatment after one year and, among those that completed the one year treatment, the number of them that completed at least 80% of the prescribed dose.

    One year

Secondary Outcomes (1)

  • Clinical study of raloxifene and strontium ranelate in postmenopausal osteoporosis

    One year

Study Arms (2)

raloxifene

ACTIVE COMPARATOR

60 mg/d for one year.

Drug: Raloxifene

strontium ranelate

ACTIVE COMPARATOR

2 g/d for one year.

Drug: Strontium ranelate

Interventions

RaloxifeneDRUG

60 mg/d for one year

Also known as: Evista
raloxifene
Strontium ranelateDRUG

2 g/d, for one year

Also known as: Protelos
strontium ranelate

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women with densitometric osteoporosis

You may not qualify if:

  • Secondary osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Dr Peset

Valencia, Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Osteoporosis, PostmenopausalPatient Compliance

Interventions

Raloxifene Hydrochloridestrontium ranelate

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Antonio Cano, MD

    University of Valencia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Obstetrics and Gynecology

Study Record Dates

First Submitted

January 18, 2012

First Posted

March 6, 2012

Study Start

September 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

ES(1)