Prospective, randomized, multicentre study to compare the efficacy at 52 weeks (1 year) of biosimilar teriparatide and alendronate in the prevention of new morphometric vertebral fractures and/or worsening of previous vertebral fractures in women with a clinical vertebral fracture or recent hip fracture (imminent risk of fracture) caused by bone fragility.

Prevention of new morphometric vertebral fractures and/or worsening of previous vertebral fractures.

The main evaluation criterion will be the percentage of patients with at least one new morphometric vertebral fracture (incident vertebral fractures) or the increase in severity of a known vertebral fracture (vertebral re-fracture) during the 52-week study period. For the diagnosis and grading of vertebral fractures, the Genant semi-quantitative method will be used on thoracic and lumbar radiographs.

new morphometric vertebral fractures or increased severity of a known vertebral fracture new clinical vertebral fractures; new non-vertebral fractures and new major non-vertebral fractures; change in BMD with respect to baseline; with respect to baseline; vertebral pain through the VAS-pain with respect to baseline & evaluation of therapeutic adherence; quality of life using the EQ-5D questionnaire with respect to baseline; frequency of AEs, SAEs, and AEs leading to treatment discontinuation

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