Fractures and Bisphosphonates: does osteoporosis treatment affect fracture healing?

Not Applicable

Completed

• Conditions: Fracture healing; Musculoskeletal Diseases

• Registration Number: ISRCTN62133820
• Lead Sponsor: niversity of Edinburgh (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30845365 [added 12/04/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-22
• Study Completion: 2013-09-29
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 421

Inclusion Criteria

Current inclusion criteria as of 19/09/2012:
1. Patients (male and female) aged 50 years and over
2. Patients must have suffered a distal radial fracture confirmed by X-ray radiograph
3. The distal radial fracture must be:
3.1. Unilateral extra-articular or minimal articular
3.2. Displaced or un-displaced
3.3. Treated with cast/splint, external fixation or open reduction and internal fixation
4. Patients willing and able to consent and comply with study protocol

Previous inclusion criteria until 19/09/2012:
3.3. Treated with cast, external fixation or open reduction and internal fixation

Exclusion Criteria

Current exclusion criteria as of 19/09/2012:
1. Any of the following:
1.1. current or previous use of zoledronic acid
1.2. current or previous use within the last 2 years of any other bisphosphonate
1.3. current or previous use within the last 6 months of strontium ranelate, calcitonin, denosumab, parathyroid hormone (PTH) or intravenous (IV), intramuscular (IM) and oral corticosteroids (inhaled corticosteroids such as asthma inhalers are acceptable)
2. Previous distal radial fracture on affected side
3. Bilateral distal radial fracture
4. Contraindications to alendronic acid, including but not limited to:
4.1. Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achlasia
4.2. Inability to stand or sit upright for at least 30 minutes
4.3. Hypersensitivity to alendronate or any of its excipients
4.4. Known hypocalcaemia
4.5. Known renal impairment
5. Women of childbearing potential not using adequate contraception
6. Pregnancy
7. The distal radial fracture is due to other pathologies e.g. Paget?s Disease of Bone, metastatic bone disease etc.

Previous exclusion criteria until 19/09/2012:
1. Any of the following:
1.1. Current or previous use of zoledronic acid
1.2. Current or previous use within the last 2 years of any other bisphosphonate
1.3. Current or previous use within the last 6 months of strontium ranelate, calcitonin, denosumab, parathyroid hormone (PTH) or intravenous (IV), intramuscular (IM) and oral corticosteroids (inhaled corticosteroids such as asthma inhalers are acceptable)
2. Previous distal radial fracture on affected side
3. Bilateral distal radial fracture
4. Contraindications to alendronic acid, including but not limited to:
4.1. Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achlasia
4.2. Inability to stand or sit upright for at least 30 minutes
4.3. Hypersensitivity to alendronate or any of its excipients
4.4. Hypocalcaemia at baseline (serum adjusted calcium <2.2mmol/l)
4.5. Renal impairment at baseline [estimated glomerular filtration rate (eGFR) less than 35ml/min as assessed by the Modification of Diet in Renal Disease (MDRD) formula]
5. Women of childbearing potential not using adequate contraception
6. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified