The purpose of this study is to find out more about romosozumab in women with postmenopausal osteoporosis. This study will see if romosozumab, given in two different forms, increases bone mineraldensity and whether it causes any side effects. To do this, romosozumab at one concentration and in one type of syringe will be compared to romosozumab at another concentration and in another type of syringe.

Conditions: Postmenopausal osteoporosis
MedDRA version: 16.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-000434-35-CZ

Lead Sponsor: Amgen, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 272

Inclusion Criteria

• Subject has provided informed consent prior to initiation of any study-specific activities/procedures
• Postmenopausal females (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 enrollment
• 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
• Subjects has at least two evaluable vertebrae in the L1-L4 region, as assessed by the principal investigator or designee
• Subject has at least one evaluable hip, 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 enrollment
- 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 smoking
- = 3 glasses of alcohol a day
- parental history of fragility (ie, osteoporosis-related) fracture
- body weight = 125 pounds/56 kilogram
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 262

Exclusion Criteria

• BMD T-score < -3.50 at the total hip or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans
• History of hip fracture
Use of agents affecting bone metabolism
• Strontium ranelate or fluoride (for osteoporosis): more than 1 month of cumulative use within 5 years prior to randomization
• 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 within 3 months prior to randomization
- more than 1 month of cumulative use between 3 and 12 months prior to randomization
• Dose received within the past 6 months prior to randomization: systemic oral or transdermal estrogen or selective estrogen receptor modulators (SERMs) (up to 1 month of cumulative use is allowed)
• Dose received within the past 6 months prior to randomization: hormonal ablation therapy (up to 1 month of cumulative use is allowed)
• Dose received within the past 3 months prior to randomization: tibolone, calcitonin, or cinacalcet
• Dose received within the past 3 months prior to randomization: systemic glucocorticosteroids (= 5 mg prednisone equivalent per day for more than 14 days)
Medical history
• 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)
• History of solid organ or bone marrow transplant
• 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, uncontrolled hyper- or hypothyroidism, defined as thyroid-stimulating hormone and thyroxine outside the normal range, per subject report or chart review
• Current, uncontrolled hyper- or hypoparathyroidism, defined as PTH outside the normal range, per subject report or chart review
• 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 upper limit of normal (ULN) as assessed by the central laboratory.
• Positive for Hepatitis B
• Positive for Hepatitis C, Chronic Hepatitis C and negative viral load while receiving treatment for Hepatitis C
• Positive for Human Immunodeficiency Virus, per subject report or chart review
• Malignacy within the last 5 years, except non-melanoma skin cancers, cervical or br

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab administered every month (QM) using a 90 mg/mL concentration compared with 210 mg romosozumab QM using a 70 mg/mL concentration on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy x-ray absorptiometry (DXA) in postmenopausal women with osteoporosis;Secondary Objective: To evaluate the effect of 6-month treatment with 210 mg romosozumab QM using romo 90 mg/mL and romo 70 mg/mL on:<br>- percent changes in DXA BMD at the total hip and femoral neck<br>- percent changes in bone turnover markers (BTM): bone formation marker procollagen type 1 N-telopeptide (P1NP) and bone resorption marker serum type I collagen C-telopeptide (CTX);Primary end point(s): Percent change from baseline in DXA BMD at the lumbar spine ;Timepoint(s) of evaluation of this end point: Month 6

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - percent change from baseline in DXA BMD at the total hip<br>- percent change from baseline in DXA BMD at the femoral neck<br>- percent change from baseline in BTMs P1NP and CTX;Timepoint(s) of evaluation of this end point: Month 6

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