Bone mineral density as a surrogate endpoint for fracture risk ...

Bone mineral density as a surrogate endpoint for fracture risk reduction in clinical trials of osteoporosis therapies: an update on SABRE

Bone mineral density as a surrogate endpoint for fracture risk reduction in clinical trials of osteoporosis therapies: an update on SABRE.

FDA Issues Timeline for Determination on FNIH-ASBMR-SABRE ...

Analysis of these data by the project team indicated a strong association between the treatment-related increase in bone mineral density, as ...

Validation of the Surrogate Threshold Effect for Change in Bone ...

In the field of osteoporosis, we have proposed that change in bone mineral density (BMD) of the total hip could be a surrogate outcome for fracture risk ...

Is bone density a valid surrogate for fracture?

ship between fracture endpoints and surrogates such as bone mineral density (BMD) or bone turnover markers. ... anism of action will reduce the risk of fracture ...

ASBMR SABRE Team Submits Full Qualification Plan to FDA for ...

... Bone Mineral Density as a Surrogate Endpoint for Future Trials of New Anti-Osteoporosis. ... fractures in future trials of new anti-osteoporosis ...

6, 7 Furthermore, observational studies consistently show that smaller BMD values are associated with greater fracture risk.8, 9 The associations between ...

FDA Approves Biomarker Qualification Plan for the First Surrogate ...

An increase in bone mineral density could therefore be used in future clinical trials to determine the effectiveness of osteoporosis drugs. The ...

analysis from the FNIH-ASBMR SABRE project | Journal of Bone ...

Compared to those with FN BMD T-score > −2.5, the risk reduction for each fracture outcome was greater in those with T-score ≤ −2.5, but only ...

Impact of bone mineral density in reducing fracture risk in patients ...

Changes in bone mineral density (BMD) are a potential surrogate marker for fracture endpoints in clinical trials. However little is known whether the ...

Validation of the Surrogate Threshold Effect for Change in Bone ...

Validation of the Surrogate Threshold Effect for Change in Bone Mineral Density as a Surrogate Endpoint for Fracture Outcomes: The FNIH‐ASBMR SABRE Project.

Validation of the Surrogate Threshold Effect for Change in Bone ...

Validation of the surrogate threshold effect for change in bone mineral density as a surrogate endpoint for fracture outcomes.

Endpoints beyond fracture promise to facilitate shorter trials, new ...

Investigators have now proposed a validated alternative outcome for fracture — change in bone mineral density — to serve as a surrogate endpoint ...

Validation of the Surrogate Threshold Effect for Change in BMD as a ...

Validation of the Surrogate Threshold Effect for Change. in Bone Mineral Density as a Surrogate Endpoint for ; Fracture Outcomes: The FNIH-ASBMR ...

is bone density a valid surrogate for fracture? - Semantic Scholar

A review of definitions of surrogate endpoints and requirements for their statistical validation indicates that the actual BMD value is correlated with ...

Change in Bone Density and Reduction in Fracture Risk: A Meta ...

Meta-analyses conducted >15 years ago reported that improvements in bone mineral density (BMD) were associated with reduction in vertebral ...

Relationship between bone mineral density changes and risk of ...

relationship between fracture endpoints and surrogates such as bone mineral density. However, studies exploring the association between BMD ...

Percent change in bone mineral density (BMD) as a surrogate ...

Percent change in bone mineral density (BMD) as a surrogate endpoint for fractures · the post value must be linearly related to the pre value ...

Biomarkers Consortium - Bone Quality Project - FNIH

The Bone Quality Team obtained FDA approval for its Letter of Intent (LOI) to qualify hip bone density as a fracture biomarker and is proceeding with its ...

Reduction of Vertebral Fracture Risk in Postmenopausal Women ...

Our study supports previous observations that the effect of fracture reduction is not clearly related to the increase in bone mineral density, suggesting that ...