A study to see the Safety and Efficacy of Abaloparatide- SC for the Treatment of Men with Osteoporosis

Phase 1

• Conditions: Osteoporosis 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]

• Registration Number: EUCTR2017-004220-30-IT
• Lead Sponsor: RADIUS HEALTH, INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-15
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 225

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 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.
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.
6. The subject has serum 25-hydroxyvitamin D values > = 20 ng/mL and within 3 times the upper normal range. Patients with serum 25-hydroxyvitamin D levels < 20 ng/ml may be treated with vitamin D and re-tested once.
7. The subject's systolic blood pressure is > = 100 and < = 155 mmHg, diastolic blood pressure is > = 40 and <= 95 mmHg, and heart rate is > = 45 and <= 100 bpm (taken sitting or supine).
8. The subject has no clinically significant abnormality of serum hemoglobin, hematocrit, WBC and platelets, or usual serum biochemistry: electrolytes, renal function, liver function and serum proteins that might be expected to interfere with the subject's health and/or medical treatment during the study.
9. In subjects who have partners of childbearing potential, the subject and his partner should abstain from sexual intercourse, or use highly
effective contraceptive measures (e.g. oral contraceptive and condom, intrauterine device (IUD) and condom, diaphragm with spermicide and
condoms, other forms of contraception must be approved by the medical monitor) when engaging in sexual intercourse throughout the study, and for at least 90 days after the last dose of abaloparatide.
10. The subject has read, understood, and signed the written informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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
or;
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.
7. Subjects with clinical signs of hypogonadism present at screening who plan to initiate testosterone replacement.
8. History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine.
9. 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 subject.
10. History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year.
11. History of significantly impaired renal function (serum creatinine >177 µmol/L or >2.0 mg/dL. If the serum creatinine is > 1.5 and < = 2.0 mg/dL, the calculated creatinine clearance (Cockcroft-Gault) must be > = 37 mL/min.
12. History of any cancer within the past 5 years (other than basal cell or squamous cancer of the skin).
13. History of osteosarcoma at any time.
14. Subjects with hereditary disorders predisposing them to osteosarcoma.
15. History of nephrolithiasis or urolithiasis within the past five years.
16. Subjects known to be positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-2. Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection or acute or chronic hepatitis. Medication-related exclusion criteria:
17. Known history of hypersensitivity to any of the test materials or related compounds.
18. Prior treatment with PTH- or PTHrP-derived drugs, including abaloparatide or teriparatide, or PTH(1-84).
19. Prior treatment with IV bisphosphonates at any time or oral bisphosphonates within the past three years. Subjects who had received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled as long as the treatment occurred 6 or more months prior to enrollment.
20. Treatment with fluoride or strontium in the past five years or prior treatment with gallium nitrate, or bone-acting investigational agents at any time.
21. Prior treatment with calcitonin or tibolone in the past 6 months.
22. Prior treatment with denosumab in the past 18 months.
23. Treatment with anticonvulsants that affect vitamin D metabolism (phenobarbital, phenytoin, carbamazepine or primidone) or with chronic
heparin within the 6 months prior to the Screening Period.
24. Treatment with anabolic steroids or calcineurin inhibitors (cyclosporin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified