Short-term Functional Recovery Between Early- and Late Bi... | NCT02148848

Studies
Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty

NCT02148848

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Sep 14, 2016Estimated

Enrollment

86Estimated

Phase

Phase 4

Conditions

Osteoporotic Fractures
Femoral Neck Fracture

Interventions

Risedronate

Countries

Thailand

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Oct 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

May 23, 2014

First Submission Date that Met QC Criteria

May 23, 2014

First Posted Date

May 28, 2014Estimated

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

Sep 13, 2016

Last Update Posted Date

Sep 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Femoral neck fracture in the elderly is one indication for initiating osteoporosis treatment. Bisphosphonates remain the first line therapy; however, many orthopaedic surgeons concern regarding their effects on fracture healing process. Therefore, therapy is usually delayed for a period of time. To the best of our knowledge, there is no scientific data to support whether bisphosphonate treatment should be given immediately after the surgery or it should be delayed.

Detailed Description

This study aims to compare functional recovery between early- and late administration of bisphosphonate in patients who received hemiarthroplasty following femoral neck fractures.

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early bisphosphonate use	Active Comparator	Give risedronate (actonel) at 2 weeks after hemiarthroplasty for an osteoporotic femoral neck fracture. In addition, calcium and vitamin D supplementation will be given to all patients. Risedronate (35 mg) 1 tablet orally once a week	Drug: Risedronate
Late bisphosphonate use	No Intervention	Give only calcium and vitamin D supplementation during the first 3 months after the surgery. Bisphosphonate, risedronate (Actonel), will be given at 3 months after surgery for an osteoporotic femoral neck fracture.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Risedronate	Drug	Take risedronate 35 mg orally every week	Early bisphosphonate use

Measure	Description	Time Frame
de Morton Mobility Index		3 months after surgery

Measure	Description	Time Frame
Barthel index		3 months after surgery
Visual analog scale score		3 months after surgery
Two minutes walking test

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient diagnosed with femoral neck fracture and was treated with bipolar hemiarthroplasty
Age more than 50 years old and bone mineral density (BMD) was in osteoporotic (T-score less than -2.5) or osteopenic (T-score between -1.0 and -2.5) ranges

Exclusion Criteria:

Patients who were treated with bipolar hemiarthroplasty for more than 2 weeks
Patients with postoperative complications which affect the postoperative rehabilitation program e.g. intraoperative cracking or fracture, postoperative cardiac complication
Have contraindications for bisphosphonates use e.g. renal insufficiency (glomerular filtration rate (GFR) < 30 ml/min), allergy to bisphosphonates, severe esophagitis, gastroesophageal reflux disease etc.
Patients with conditions/disorders which have an affect on bone mineral density or bone metabolism e.g. renal insufficiency, rheumatoid arthritis, Paget's disease, renal osteodystrophy, hyperparathyroidism, glucocorticoids use etc.
History of bisphosphonates use within 12 months
Open fracture, multiple fracture or multiple trauma patients
Pathological fracture
Bilateral lower extremity fractures
The pre-injury functional status of the patients is non-ambulatory

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aasis Unanantana, M.D.	Contact	(66)24197968		uaasis@gmail.com
Panai Laohaprasitiporn, M.D.	Contact	(66)24197968		p_you_n@hotmail.com

Overall Officials

Name	Affiliation	Role
Aasis Unnanuntana, MD	Siriraj Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Siriraj Hospital	Recruiting	Bangkoknoi	Bangkok	10700	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28283937	Derived	Unnanuntana A, Laohaprasitiporn P, Jarusriwanna A. Effect of bisphosphonate initiation at week 2 versus week 12 on short-term functional recovery after femoral neck fracture: a randomized controlled trial. Arch Osteoporos. 2017 Dec;12(1):27. doi: 10.1007/s11657-017-0321-8. Epub 2017 Mar 10.

Type	Date	Date Unknown
Release	May 1, 2017
Reset	Aug 11, 2017
Release	Aug 12, 2017
Reset	Feb 15, 2018
Release	Mar 26, 2018
Reset	Nov 2, 2018
Release	Sep 1, 2021
Reset	Sep 28, 2021

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 1, 2017			Aug 11, 2017
Aug 12, 2017

ID	Term
D058866	Osteoporotic Fractures
D005265	Femoral Neck Fractures
D010024	Osteoporosis

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D006620	Hip Fractures
D005264	Femoral Fractures

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals