Osteoporosis Clinical Trials

• Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age and less than 92 years of age.

• Subject presents with a low-energy index fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.

• Subject has at least one of the following additional risk factors for a secondary hip fracture (as determined by subject or legally authorized representative (LAR) interview or medical record review):

‣ Documented falls assessment indicating subject is at moderate or high risk of falls

⁃ Falls history (2 or more falls in the previous 12 months)

⁃ History of vertigo, dizziness, or postural hypotension

⁃ Documented T-score \< -2.5 at the hip

⁃ Taking more than 3 daily prescription medications

⁃ Visual impairment as confirmed by one of the following:

• Subject reports difficulty seeing

∙ Lack of depth perception or vision loss in one eye

∙ Macular degeneration

∙ Cataracts

⁃ Prior non-hip fragility fracture

⁃ Cognitive frailty as assessed by SPMSQ (mild cognitive impairment determined by SPMSQ ≤ to 4) or delirium

⁃ Parkinson's disease stage 3 or 4

⁃ 10-year hip fracture probability \>15% using the FRAX® Fracture Risk Assessment Tool of the clinical site country

• Subject is expected to be ambulatory after the hip fracture repair procedure. Ambulatory is defined as a patient's ability to ambulate beyond simple transfers with or without assistive devices.

• Informed consent is provided by the subject or the subject's LAR. Use of an LAR to obtain patient consent requires that the patient must understand and be able to participate in post operative restrictions and requirements.

• The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full duration of the study has been documented.