The administration of Parathyroid hormone affects functional recovery from pertrochanteric fractured neck of femur: A prospective randomised comparative pilot study with blinded objective functional outcome assessment. - Parathyroid Hormone in the recovery from hip fractures - a pilot study

• Conditions: Osteoporotic or low energy pertrochanteric hip fractures

• Registration Number: EUCTR2010-020081-22-GB
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Participants must be 60 years and over admitted to North Bristol NHS Trust with a pertrochanteric femoral fracture.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients fulfilling any of the following criteria would be excluded from the trial.
1.Fracture not result of low energy trauma e.g fall from standing height
2.Conservative treatment
3.Surgical fixation with THR, hemiarthroplasty or cannulated screws
4.Previous treatment with PTH or other PTH analogues
5.Previous IV bisphosphonates e.g Zoledronic acid infusion in the previous 12 months
6.Previous treatment with Strontium in the previous 12 months
7.Current medications for breast and prostrate cancer (e.g tamoxifen, anastrozole, zoladex, prostap) or other current hormone therapy e.g. testerone, HRT
8.Decreased capacity to understand and the weigh the risks and benefits of participating in the trial
9.Presence of a metabolic bone disease e.g. Pagets disease of hyperparathyroidism
10.High or Low corrected calcium which requires investigation
11.Severe renal failure, urolithiasis or hypercalcaemia
12.Unexplained raised alkaline phosphatase
13.Active cancer diagnosis or skeletal malignances or bone metastases, or prior external beam or implant radiation therapy to skeleton within the last five years
14.Pre-menopausal, Pregnancy or lactation
15.Sustained use of oral steroids
16.Wheelchair, bed bound or transfers only prior to fracture
17.Other fractures that will affect ability to mobilise at 6 weeks
18.Physical capability to carry out treatment protocol or appropriate social circumstances (e.g. needle phobia, other severe disabilities limiting manipulation injection pen and without appropriate carer willing and able to assist)
19.Patient consents to study >7 days post surgery
20.Patients currently involved in other clinical trial of medicinal products

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified