Improving the outcome for patients after osteoporotic femoral fractures - Improving the outcome for patients after osteoporotic femoral fracture

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015058-38-GB

Enrollment

120

Registered

2010-08-17

Start date

2010-10-22

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OSTEOPOROTIC FEMORAL FRACTURE

Interventions

Trade Name: FOSAMAX Product Name: FOSAMAX Product Code: NDC 006-0031-44 Pharmaceutical Form: Tablet INN or Proposed INN: Alendronate Sod

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with acute traumatic trochanteric or supracondylar femoral fractures and fragility fractures (i.e. sustained from standing height or less and radiological features of osteoporosis). - Patients who are aged 55 or older. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Patients with open fractures, pathological fractures, ‘floating knee’, associated patellar fractures or simultaneous bilateral fractures - Patients with a known metabolic bone disease, rheumatoid arthritis or chronic renal failure - Patients with dementia - Patients with bone metastases or other malignant bone disease - Patients taking steroids, strontium, biphosphonates or PTH -Patients with oesophageal abnormalities, swallowing problems, hypocalcaemia, hypercalcemia. - Women of child-bearing age (<55years), pregnant or breast feeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: To produce preliminary evidence testing the hypothesis that it is possible to accelerate the healing of trochanteric and distal femoral fractures with the administration of therapeutic agents (Parathyroid Hormone, Biphosphonate, Vitamin D and Calcium) and thus reduce pain and functional impairment at 3 and 6months.;Primary end point(s): Pain and functional assessment as indicated by the Johanson Hip Rating Questionnaire(HRQ). We would expect to see a difference of between seven and ten points in the overall HRQ score from baseline assessment to 6 months post-operatively. However due to the pilot character of this trial is expected mostly to produce preliminary evidence testing the hypothesis that it is possible to accelerate the healing of trochanteric and distal femoral fractures with the administration of therapeutic agents and thus reduce pain and functional impairment at 3 and 6 months.;Secondary Objective: - To compare the radiological healing rates at 3 and 6months post-operatively. - To compare the complication rates post-operatively. - To evaluate the feasibility of performing the protocol procedures in preparation for a pivotal study on the same subject.	—

Measure

Time frame

Main Objective: To produce preliminary evidence testing the hypothesis that it is possible to accelerate the healing of trochanteric and distal femoral fractures with the administration of therapeutic agents (Parathyroid Hormone, Biphosphonate, Vitamin D and Calcium) and thus reduce pain and functional impairment at 3 and 6months.;Primary end point(s): Pain and functional assessment as indicated by the Johanson Hip Rating Questionnaire(HRQ). We would expect to see a difference of between seven and ten points in the overall HRQ score from baseline assessment to 6 months post-operatively. However due to the pilot character of this trial is expected mostly to produce preliminary evidence testing the hypothesis that it is possible to accelerate the healing of trochanteric and distal femoral fractures with the administration of therapeutic agents and thus reduce pain and functional impairment at 3 and 6 months.;Secondary Objective: - To compare the radiological healing rates at 3 and 6months post-operatively. - To compare the complication rates post-operatively. - To evaluate the feasibility of performing the protocol procedures in preparation for a pivotal study on the same subject.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026