Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday

Osteoporosis Clinical Trial

— CONTINUITY  

Official title:

Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday: Data From a Single Outpatient Endocrine Clinic.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01854086
• Other study ID #: MMC130009-13CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: May 6, 2013
• Last updated: May 12, 2013
• Start date: September 2013

Study information

• Verified date: May 2013
• Source: Meir Medical Center
• Contact: Pnina Rotman, M.D
• Phone: 972-57-7482609
• Email: Pnina.Rotman[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational [Patient Registry]

Clinical Trial 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".

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Questionnaires about compliance and persistence with bisphosphonates treatment

Locations

Country	Name	City	State
Israel	Meir medical center the clalit health care services group	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No