Study of Post Menopausal Osteoporosis (PMO) Among Gynecol... | NCT02422069

Studies
Study of Post Menopausal Osteoporosis (PMO) Among Gynecology Outpatients in Pakistan

NCT02422069

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

624Actual

Phase

Not provided

Conditions

Postmenopausal Osteoporosis

Interventions

Not provided

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Apr 16, 2015

First Submission Date that Met QC Criteria

Apr 16, 2015

First Posted Date

Apr 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

Brief Summary

This observational study will provide an opportunity to document local patterns of susceptibility, patient profile, and usefulness of screening in postmenopausal patients coming to gynecology outpatient clinics in Pakistan. This will also capture the initial management of PMO in diagnosed patients. The information gathered will serve as a foundation for developing national guidelines on screening and management of PMO in Pakistan.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

624Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Population		Gynecology outpatients who meet eligibility criteria will be enrolled and evaluated for the presence of PMO at screening. Women diagnosed with PMO will complete an additional visit to document the prescribed management plan.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients diagnosed with PMO based upon dual-energy X-ray absorptiometry (DXA) results		Up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Use of various PMO treatment modalities		Up to 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal women
Age 50 years or greater

Exclusion Criteria:

Previously diagnosed osteoporosis, or receiving treatment for osteoporosis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study will enroll gynecology outpatients in Pakistan who meet eligibility criteria for observation.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D015663	Osteoporosis, Postmenopausal

Ancestor Terms

ID	Term
D010024	Osteoporosis
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Islamabad			Pakistan