An observational study of postmenopausal women with osteoporosis

Phase 4

Completed

Conditions: Health Condition 1: null- Osteoporosis

Registration Number: CTRI/2013/08/003902

Lead Sponsor: Merck Sharp and Dohme

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 3600

Inclusion Criteria

Postmenopausal women, defined as no menstruation for the last 12 months.

At least 50 years of age at enrollment.

Determined to have osteoporosis based on their physicians judgment (with or without bone mineral density evaluation)

For the untreated group, participants should be treatment naÃ¯ve for Osteoporosis medications.

For the treated group, patients are divided into new users and experienced users.

For the new user cohort participants should be taking osteoporosis medications for less than 3 months and should be treatment naive prior to commencing therapy. Experienced Users are participants who have been receiving the same oral pharmacological therapy for at least 3 months continuously and are continuing treatment at the time of enrollment

Willing and able to complete all scheduled followup questionnaire assessments during the 12 month followup (except for untreated participants).

Willing to provide informed consent and be willing and able to follow the study protocol.

Exclusion Criteria

1)Diagnosed with Parkinsonâ??s disease or any other neuromuscular disease.

2)Diagnosed with Pagetâ??s disease.

3)Currently or previously diagnosed with a malignant neoplasm

4)Currently treated with any injectable medication for osteoporosis including intravenous bisphosphonates, subcutaneous PTH or denosumab (Refer to Appendix 2 for a list of injectable medications for osteoporosis).

5)Switched between oral pharmacological osteoporosis medications having different active ingredients within the 3 months prior to study entry.

6)Considered by the investigator to be unwilling or unable to complete the study or comply with the protocol.

7)Involved in any active litigation or compensation issues including disability dispute cases with government.

8)Currently enrolled in an interventional clinical trial or have participated in an interventional clinical trial within the past 3 months.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Osteoporosis medications, gastrointestinal events, medication adherence, health care resource utilization, treatment satisfaction, health related quality of life, treatment concernsTimepoint: baseline and follow up at 3,6 and 12 months

Secondary Outcome Measures

Name	Time	Method
1)Describe the physicians treatment approach among post-menopausal women (â?¥ 50 years age) with osteoporosis having either a history or incidence of GI events <br/ ><br>2)To estimate the proportion of patients with pharmacological osteoporosis treatment among post-menopausal women (â?¥ 50 years age) with osteoporosis <br/ ><br>3)To understand the factors associated with treatment choice (treatment vs. non-treatment) in clinical practice from both physician and participant perspective <br/ ><br> <br/ ><br>Timepoint: NAP