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.

Radius Health, Inc.0 sites225 target enrollmentJune 15, 2018

ConditionsOsteoporosis in men MedDRA version: 20.0Level: PTClassification code 10031282Term: OsteoporosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

DrugsTYMLOS (abaloparatide) injection, for subcutaneous use

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Osteoporosis in men
Sponsor: Radius Health, Inc.
Enrollment: 225
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 15, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Radius Health, Inc.

Eligibility Criteria

Inclusion Criteria

•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 male 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 a clinically significant abnormality in the opinion of the Investigator, or none for which there is a reasonable chance of interfering with the subject’s health and/or medical treatment during the study. The subject has a body mass index (BMI) of 18\.5 to 33, inclusive. The body mass index is derived from the subject's height and weight. In the case where a subject's height cannot be adequately assessed (e.g., due to vertebral compression fractures or scoliosis), the subject's historical height (as documented in the subject's medical record) will be used to derive the BMI.
•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.
•5\. The subject has serum calcium (albumin\-corrected), PTH, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone (TSH) values all within the normal range during the Screening Period. Any subject with an elevated alkaline
•phosphatase value and who meets all other entry criteria must have a normal bone\-specific alkaline phosphatase to be enrolled. Any subject with a TSH value outside of the normal range must have central laboratory reported T3 and free T4 values within the normal ranges to be enrolled.
•6\. The subject has serum 25\-hydroxyvitamin D values \= 20 ng/mL and within 3 times the upper normal range. Subjects with serum 25\-hydroxyvitamin D levels \< 20 ng/ml may be treated with vitamin D and re\-tested once during the Screening Period.

Exclusion Criteria

•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 male 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.