NCT01854086

Brief Summary

The purpose of the study is to provide information about the rate of response and persistence to drug therapies for osteoporosis. Another issue examined in this study refers to the preferences and concerns about future treatments in patients during "drug holiday".

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2013

Enrollment Period

5 months

First QC Date

May 6, 2013

Last Update Submit

May 12, 2013

Conditions

Keywords

osteoporosispostmenopausalpatient compliancecompliancediphosphonatesbisphosphonates

Outcome Measures

Primary Outcomes (1)

  • Compliance and persistence to osteoporosis drug therapy

    Data collection will be done by questionnaires and from the medical record of the patient. The information collected will include: demographic information, measurements of bone density, additional information about the disease and treatment that the patient receives,prescription purchases and additional drugs the patient is taking (steroids, PPI's(Proton Pump Inhibitors) / H2 receptor antagonists and NSAIDs(Non Steroidal Anti Inflammatories)).

    Participants will be followed for the duration of their clinic visit, an average of 5 hours

Study Arms (1)

Postmenopausal women

Postmenopausal women treated with bisphosphonates

Other: Questionnaires about compliance and persistence with bisphosphonates treatment

Interventions

Eligibility Criteria

Age40 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with osteoporosis,who been treated in Endocrinology Clinic of Medical Center

You may qualify if:

  • Postmenopausal women
  • Diagnosis of osteoporosis in the medical record
  • At least one prescription drug to treat osteoporosis in the last 5 years
  • Insured by "Clalit" Health Services
  • Hebrew-speaking capability and readiness to answer a questionnaire

You may not qualify if:

  • Premenopausal women
  • No diagnosis of osteoporosis in the medical record
  • No treatment for osteoporosis in the last 5 years
  • Women who do not speak Hebrew or are unable to answer a questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir medical center the clalit health care services group

Kfar Saba, 44281, Israel

Location

Related Publications (1)

  • Cramer JA, Amonkar MM, Hebborn A, Altman R. Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis. Curr Med Res Opin. 2005 Sep;21(9):1453-60. doi: 10.1185/030079905X61875.

MeSH Terms

Conditions

OsteoporosisPatient Compliance

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2013

First Posted

May 15, 2013

Study Start

September 1, 2013

Primary Completion

February 1, 2014

Last Updated

May 15, 2013

Record last verified: 2013-05

Locations