Purpose

A 12 month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.

Conditions

Eligibility

Eligible Ages
Between 40 Years and 85 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Healthy ambulatory male from 40 to 85 years of age (inclusive) with primary osteoporosis or osteoporosis associated with hypogonadism.
  • The patient has a BMD T-score (based on the female reference range as assessed by the central imaging vendor) of ≤ -2.5 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by DXA or ≤-1.5 and with radiologic evidence of vertebral fracture or a documented history of low-trauma nonvertebral fracture sustained in the past 5 years. 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.
  • Normal medical history, physical examination, including vital signs, and body mass index (BMI).
  • Hypogonadal patients whose doses of androgens have been stable for at least twelve months before randomization are eligible and may continue therapy during the study.
  • Laboratory tests within the normal range including serum calcium (albumin-corrected), PTH, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone (TSH) values.

Exclusion Criteria

  • 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.
  • A BMD T-score of ≤-3.5 at the total hip, femoral neck, or lumbar spine based upon the female reference range.
  • Unevaluable hip BMD or patients who have undergone bilateral hip replacement.
  • Fragility fracture within the prior twelve months.
  • History of severe vertebral fracture or >2 moderate vertebral fractures.
  • History of bone disorders (e.g., Paget's disease) other than osteoporosis.
  • Patients with clinical signs of hypogonadism present at screening who plan to initiate testosterone replacement.
  • History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine.
  • History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the patient.
  • History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized patients will received a 2:1 ratio of abaloparatide:placebo injections.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Treatment will be blinded to participants, investigators, outcome Assessor and care provider throughout the study except in a medical emergency where the identity of study medication is necessary to appropriately treat the patient.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Abaloparatide (BA058)
Abaloparatide is an active synthetic peptide of parathyroid hormone
  • Drug: Abaloparatide
    Abaloparatide 80 mcg subcutaneous daily
    Other names:
    • TYMLOS®
    • BA058
    • abaloparatide-SC
Placebo Comparator
Placebo
Placebo with no peptide of parathyroid hormone
  • Drug: Placebo
    Placebo 0 mcg subcutaneous daily

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

More Details

Status
Recruiting
Sponsor
Radius Health, Inc.

Study Contact

Radius Health, Inc.
617-551-4002
info@radiuspharm.com

Detailed Description

The primary objective of this prospective controlled study is to evaluate the efficacy and the safety of abaloparatide-SC 80 mcg per day compared to placebo as assessed by change in bone mineral density over 12 months.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.