A Comparison of Subject-administered Romosozumab with Healthcare Provider-administered Romosozumab for Osteoporosis

Phase 1

Conditions: Postmenopausal osteoporosis
MedDRA version: 20.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Registration Number: EUCTR2017-003512-40-GB

Lead Sponsor: Amgen Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 260

Inclusion Criteria

• Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures, or subject’s legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
• Postmenopausal female (postmenopausal status is defined as no vaginal bleeding or spotting for 12 consecutive months prior to screening).
• = 55 to = 90 years of age at the time of informed consent
• Ambulatory
• BMD T-score = -2.50 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans
• Subject has at least 2 vertebrae in the L1-L4 region evaluable by DXA, as assessed by the principal investigator or designee
• Subject has at least 1 hip evaluable by DXA, as assessed by the principal investigator or designee
• Subject has history of fragility (ie, osteoporosis-related fracture) or subject meets at least 2 of the following clinical risk factors for fracture:
- = 70 years of age at the time of informed consent
- BMD T-score = -3.00 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans
- current smoker
- consumption of = 3 glasses of alcohol a day
- parental history of fragility (ie, osteoporosis-related) fracture
- body weight = 125 pounds/56 kilogram
• Ability to follow and understand instructions and the ability to self-inject, per investigator judgement
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 87
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 173

Exclusion Criteria

Disease-Related
• History of ONJ and/or AFF
• History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as sclerosteosis, Paget’s disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia, and malabsorption syndrome
• Subject with reported history of hearing loss associated with cranial nerve VIII compression due to excessive bone growth (eg, as seen in conditions such as Paget’s disease, sclerosteosis and osteopetrosis)
• Vitamin D insufficiency [defined as serum 25 (OH) vitamin D levels < 20 ng/mL], as determined by the central laboratory. Vitamin D repletion will be permitted and subjects may be rescreened.
• Current hyperthyroidism (unless well controlled on stable antithyroid therapy) by subject report or by chart review, per principal investigator evaluation
• Current clinical hypothyroidism (unless well controlled on stable thyroid replacement therapy) by subject report or by chart review, per principal investigator evaluation
• Current, uncontrolled hyper- or hypoparathyroidism, defined as PTH outside the normal range, per subject medical history. Uncontrolled hyperparathyroidism is defined as: parathyroid hormone (PTH) outside the normal range in subjects with concurrent hypercalcemia; or PTH values > 20% above the upper limit of normal (ULN) in normocalcemic subjects.
• Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory. Serum calcium levels may be retested once in case of an elevated serum calcium level within 1.1x the ULN as assessed by the central laboratory
Other Medical Conditions
• Malignancy, except non-melanoma skin cancers or cervical or breast ductal carcinoma in situ within the last 5 years
• Possible diagnosis of multiple myeloma or related lymphoproliferative disorder, as assessed by serum protein electrophoresis performed by the central laboratory and interpreted by the investigator
• Evidence of acute or chronic hepatitis B or hepatitis C virus. Hepatitis status will be evaluated by testing for hepatitis B surface antigen (HepBsAg), total hepatitis B core antibody (HepBcAb) and hepatitis C antibody by the central laboratory at initial screening. Polymerase chain reaction (PCR) should be performed to confirm active disease only if total HepBcAb is positive and HepBsAg is negative or if C antibody is positive.
• Positive for Human Immunodeficiency Virus, per subject report or chart review Prior/Concomitant Therapy
• Strontium ranelate or fluoride (for osteoporosis): more than 1 month of cumulative use within 5 years prior to randomization
• Intravenous (IV) bisphosphonates
Zoledronic acid:
- any dose received within 3 years prior to randomization
- more than 1 dose received within 5 years prior to randomization
IV ibandronate or IV pamidronate:
- any dose received within 12 months prior to randomization
- more than 3 years of cumulative use, unless last dose received = 5 years prior to randomization
• Dose received within the past 18 months prior to randomization: denosumab or any cathepsin K inhibitor, such as odanacatib (MK-0822)
• Teriparatide or any PTH analogs
- any dose received within 3 months prior to randomization
- more than 1 month of cumulative use between 3 and 12 months prior to Randomization
• Oral bisphosphonates
- any dose received

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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