Study identification

PURI

https://redirect.ema.europa.eu/resource/104775

EU PAS number

EUPAS104033

Study ID

104775

Official title and acronym

Effectiveness of antiresorptives in preventing hip fractures in older women (≥ 75 years) with osteoporosis: nested case-control study cohort (BiHip)

DARWIN EU® study

No

Study countries

Spain

Study description

JUSTIFICATION: When antiresorptive came on the market, they had demonstrated efficacy in improving bone density. However, in most of the fundamental trials the results showed no clear potential benefit in reducing the risk of hip fracture. Several meta-analyses of antiresorptives have been carried out, reporting a statistically significant but clinically questionable benefit. HYPOTHESIS: The analysis of population cohort data has become a tool for assessing the real-life effectiveness of certain drugs. Antiresorptives may have a limited impact on preventing hip fractures in older osteoporotic women. GENERAL OBJECTIVE: To determine the real-life effectiveness of antiresorptive treatment in preventing hip fractures in older women (≥ 75 years) with osteoporosis. SPECIFIC OBJECTIVES: Analyze the risk of hip fracture in older women (≥ 75 years) with osteoporosis exposed to each group of collected antiresorptive versus those who do not have it. Analyze the risk of hip fracture in older women with osteoporosis exposed to antiresorptives versus those who do not have it, depending on when they receive treatment and its duration. The study will be nested case-control within a BIFAP cohort with the following inclusion criteria: Women aged ≥ 75 years. Diagnosis of osteoporosis Exclusion criteria History of cancer (excluding basal cell skin) Paget’s disease, rheumatoid arthritis, polymyalgia rheumatica or ankylosing spondylitis Patients taking oral corticosteroids for more than 3 months History of high impact trauma hip fracture Event: hip fracture Main exposure: antiresorptives Adjustment variables: confounding factors for osteoporosis

Study status

Planned
Research institution and networks

Institutions

Contact details

Cedeño Veloz Bernardo Abel

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
EU institutional research programme
Non for-profit organisation (e.g. charity)
Other
Pharmaceutical company and other private sector 

More details on funding

None, None, Osasunbidea, None, None
Study protocol
Initial protocol

Protocolo del estudio V3 27-02-23

English (332.69 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable