Parathyroid hormone in the recovery from hip fractures: a pilot study

Completed

• Conditions: Hip fractures; Injury, Occupational Diseases, Poisoning; Hip fracture

• Registration Number: ISRCTN03362357
• Lead Sponsor: orth Bristol NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients admitted to Frenchay Hospital with diagnosis of a pertrochanteric femoral fracture over the age of 60 years (either sex)

Exclusion Criteria

Patients with any of the following would be excluded from the trial:
1. Fracture not as a result of a low energy injury/fall for example fall from standing height
2. Patients whose fracture is managed conservatively
3. Surgical fixation with total hip replacement (THR), hemiarthoplasty or cannulated screws
4. Previous treatment with PTH or other PTH analogues.
5. Hypersensitivity to the active substance or to any of the excipients.
6. Previous IV bisphosphonate (e.g. Zoledronic acid) in the previous 12 months
7. Strontium therapy for osteoporosis within the previous12 months
8. Current medications for breast and prostate cancer (e.g. tamoxifen, anastrozole, zoladex, prostap) or other hormone therapies such as testosterone, HRT
9. Decreased capacity to understand the risks of participating in the trial,
10. Metabolic bone disease e.g. Pagets disease & hyperparathyroidism other than primary osteoporosis or glucorticoid-induced osteoporosis.
11. Pre-existing hypercalcaemia or high or low corrected calcium which requires investigation.
12. Severe renal failure (EGFR <30) or urolithiasis
13. Unexplained raised alkaline phosphatase,
14. Active cancer diagnosis or skeletal malignancies or bone metastases or prior external beam or implant radiation therapy to skeleton within the last five years.
15. Premenopausal
16. Pregnancy or lactation
17. Sustained use of oral steroids
18. Wheelchair, bed bound or transferring only prior to fracture
19. Other fractures that will affect ability to mobilise at 6 weeks
20. Physically incapable to carry out treatment protocol or appropriate social circumstances (e.g. needle phobia, other severe disabilities limiting manipulation of injection pen and without appropriate carer willing and able to assist)
21. Patient consents to study >7 days post surgery
22. Current participation in any other clinical trial of medicinal product

Study & Design

• Study Type: Interventional
• Study Design: Not specified