Clinical trial NCT02148848: Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty
Official title: A Comparative Study of Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty in Patients With Osteoporotic Femoral Neck Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoporotic Fractures
Femoral Neck Fracture
Keywords: Osteoporosis
Femoral neck fracture
hemiarthroplasty
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 86
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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.

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

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

Primary outcomes:
measure: de Morton Mobility Index
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Barthel index
timeFrame: 3 months after surgery
measure: Visual analog scale score
timeFrame: 3 months after surgery
measure: Two minutes walking test
timeFrame: 3 months after surgery
measure: Timed get up and go test
timeFrame: 3 months after surgery
measure: EuroQoL-5D (EQ-5D)
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Aasis Unnanuntana, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.