A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men with Osteoporosis - n.a.

RADIUS HEALTH, INC0 sites225 target enrollmentJanuary 15, 2021

Overview

No summary available.

Registry

who.int

Start Date

January 15, 2021

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•1\. The subject is a healthy ambulatory male from 40 to 85 years of age (inclusive) with primary osteoporosis or osteoporosis associated with
•hypogonadism.
•2\. The subject has a bone mineral density (BMD) T\-score (based on the female reference range as assessed by the central imaging vendor) of
•a. \<\= –2\.5 at the lumbar spine (L1–L4\) or hip (femoral neck or total hip) by DXA or
•b. \<\=–1\.5 and with radiologic evidence of vertebral fracture or a documented (radiograph films or report) history of low\-trauma nonvertebral fracture sustained in the past 5 years.
•c. Men older than 65 years may be enrolled if they have a BMD T\-score \<\= –2\.0 even if they do not meet the fracture criteria.
•3\. The subject is in good general health as determined by medical
•history and physical examination (including vital signs), has a body mass index (BMI) of 18\.5 to 33, inclusive, and is without evidence of clinically
•significant abnormality in the opinion of the Investigator, or one for which there is a reasonable chance of interfering with the subject's health and/or medical treatment during the study.
•4\. Hypogonadal subjects whose doses of androgens have been stable for at least twelve months before randomization are eligible and may continue therapy during the study.

•General exclusion criteria
•1\. Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bone mineral density, defined as having at least 2 radiologically evaluable vertebrae within L1–L4 as assessed by the
•central imaging vendor. Anatomically abnormal vertebrae are excluded if:
•o They are clearly abnormal and non\-assessable within the resolution of the system
•o There is a more than 1\.0 T\-score difference between the vertebra in question and adjacent vertebrae.
•2\. A BMD T\-score of \<\= –3\.5 at the total hip, femoral neck, or lumbar spine based upon the female reference range.
•3\. Unevaluable hip BMD or subjects who have undergone bilateral hip replacement (unilateral hip replacement is acceptable).
•4\. Fragility fracture within the prior twelve months.
•5\. History of severe vertebral fracture or \> 2 moderate vertebral fractures.
•6\. History of bone disorders (e.g., Paget's disease) other than osteoporosis.