NCT02148848

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

4.3 years

First QC Date

May 23, 2014

Last Update Submit

September 13, 2016

Conditions

Osteoporotic FracturesFemoral Neck Fracture

Keywords

OsteoporosisFemoral neck fracturehemiarthroplasty

Outcome Measures

Primary Outcomes (1)

  • de Morton Mobility Index

    3 months after surgery

Secondary Outcomes (5)

  • Barthel index

    3 months after surgery

  • Visual analog scale score

    3 months after surgery

  • Two minutes walking test

    3 months after surgery

  • Timed get up and go test

    3 months after surgery

  • EuroQoL-5D (EQ-5D)

    3 months after surgery

Study Arms (2)

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

RisedronateDRUG

Take risedronate 35 mg orally every week

Also known as: Actonel
Early bisphosphonate use

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28283937DERIVED

MeSH Terms

Conditions

Osteoporotic FracturesFemoral Neck FracturesOsteoporosis

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesHip FracturesFemoral FracturesHip InjuriesLeg InjuriesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Aasis Unnanuntana, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aasis Unanantana, M.D.

CONTACT

(66)24197968uaasis@gmail.com

Panai Laohaprasitiporn, M.D.

CONTACT

(66)24197968p_you_n@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2014

First Posted

May 28, 2014

Study Start

June 1, 2013

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

TH(1)