Assessing Daily-activity-level for Decisions on Bisphosphonate Prescription (ADD-BP) Study: Exploring Physical Activity as a Risk Factor for Bisphosphonate-Induced Atypical Femoral Fractures

JRCT ID: jRCT1020230053

Registered date:22/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atypical Femoral Fracture
• Date of first enrollment: 22/01/2024
• Target sample size: 140
• Study type: Observational

Outcome(s)

• Primary Outcome: Performing a multiple logistic regression analysis to assess the odds ratios for the occurrence of atypical femoral fractures (AFF) in relation to pre-injury activities of daily living (ADL) and seven confounding factors.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable

Include criteria

Prior to December 2023, the study targets inpatients with a history of bisphosphonate (BP) use in the Fukushima Prefectural Medical University Hospital, Ohara General Hospital, Fukushima Red Cross Hospital, Nanto-Tohoku Fukushima General Hospital, and the Public Fujita General Hospital, all located in the northern region of Fukushima Prefecture.

*Patients with a history of the use of alendronate, risedronate, minodronate, ibandronate, etidronate, and zoledronic acid are considered to have a history of BP use.

The study population consists of patients with atypical femoral fractures (AFF). The control group comprises inpatients without AFF, and the same number of samples will be randomly selected as in the case group.

Patients with a history of BP use among inpatients will be listed and assigned numbers, and a random selection will be made. The number of patients sampled will be adjusted based on the size of each facility's patient population (proportional probability sampling).

• Exclude criteria: Patients treated with zoledronic acid for hypercalcemia due to malignant tumors, bone lesions caused by multiple myeloma, and bone lesions resulting from bone metastasis of solid cancers.

Related Information

• Primary Sponsor: Yokota Takeru