Fracture healing Musculoskeletal Diseases Fracture healing
Conditions
Interventions
Participants are allocated to receive either 70mg alendronic acid or placebo once-weekly for 24 weeks. It will be compared against a matched placebo. Participants will take study medication for 24 wee
Sponsors
University of Edinburgh (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Comparing the fracture healing between both arms at 4 weeks using X-rays 2. Fractures will be defined as healed when the following features are present: 2.1. Bridging of three out of four cortices 2.2. Radiographic evidence of endosteal healing 2.3. Organised trabecular bridging 3. Also, a time to event analysis will also be performed to evaluate the trajectory of fracture healing from radiographs taken at 2, 4, 6 and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Upper limb function will be assessed by using the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure 2. The DASH is a validated 30-item questionnaire which has previously been shown to detect changes of disability over time after injury or surgery in patients with upper-extremity musculoskeletal disorders 3. The effect of alendronate on the DASH score during the trial will be measured by comparing the change in DASH score from initial fracture to each timepoint (baseline, 2, 4, 6, 8 and 26 weeks) for both treatment groups 4. Complex Regional Pain Syndrome type I will be assessed at weeks 6 and 26 using the clinical Budapest Criteria 5. Pain will be assessed using an 11 point (0-10) Numeric Rating Scale (NRS) and by recording the amount of analgesia used in the 24 hours prior to questioning 6. Participants will be asked rank their pain from 0 (no pain) to 10 (worst pain imaginable) 7. The difference in pain and analgesia use at baseline, weeks 2, 4, 6, 8, and 26 will be compared between both treatment groups 8. Active range of movement (AROM) and grip strength of both the affected and unaffected hand will be measured at weeks 8 and 26, using a goniometer and hand dynamometer respectively 9. The differences between the range of movement and grip strength in each hand will be used to compare the two treatment groups | — |
Countries
United Kingdom
Outcome results
None listed