Osteoporosis
Conditions
Keywords
Prolia, Denosumab, AMG 162, Osteoporosis
Brief summary
The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months.
Interventions
DRUGProlia
Partcipants will receive subcutaneous (SC) injections of Prolia Q6M.
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Ambulatory Chinese men aged ≥ 30 years and ≤ 90 years old at the time of signing the informed consent. * Men at the time of screening will be required to have lumbar spine or total hip BMD T-score ≤ -2.5 or T-score ≤ -1.5 and a history of a fragility fracture. * Have to have at least two intact vertebrae at baseline (L1-L4).
Exclusion criteria
* Any condition that could affect bone metabolism such as Paget's disease of bone, osteomalacia including secondary causes of osteoporosis (subjects with low testosterone levels are allowed). * Hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on thyroid hormone replacement therapy are allowed. * Participants with a history of any cancer (cured basal cell or squamous cell cancers are allowed). * Any condition that in the opinion of the investigator would not allow the subject to complete 1 year study and comply with the requirement of the study protocol. * Hypogonadism requiring testosterone replacement therapy unless on a stable dose for at least 12 months. * Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate. Systemic glucocorticoids: ≥ 7.5 mg prednisone equivalent per day for more than 14 days within 3 months before randomization. Any bone anabolic treatment within 1 year. Anabolic steroids or testosterone: any use within 6 months before randomization. * Oral bisphosphonates treatment. * Known to have tested positive for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen, or cirrhosis of the liver. * Received any solid organ or bone marrow transplant or is on chronic immunosuppression for any reason. * Oral/dental conditions that would require an intervention including tooth extraction during the course of the study and invasive dental work (per local oral surgeon's assessment) planned in the next 12 months. * Any prior use of products containing denosumab. * Currently receiving treatment in another investigational device or drug study, or less than 1 month since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. * Vitamin D levels \< 20 ng/mL (subjects are allowed into the study after vitamin D levels are corrected and subjects re-screened). * Albumin-adjusted serum calcium levels \< 8.5 mg/dl or \> 10.5 mg/dl.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12 | Baseline and Month 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from baseline in serum C-terminal telopeptide (CTx) at month 3, 6, 9, and 12 | Baseline and Months 3, 6, 9, and 12 |
| Percent change from baseline in serum procollagen Type 1 N-Telopeptide (P1NP) at month 3, 6, 9, and 12 | Baseline and Months 3, 6, 9, and 12 |
| Percent change from baseline in total hip and femoral neck BMD at month 6 and 12 | Baseline and Months 6 and 12 |
| Percent change from baseline in lumbar spine BMD at month 6 | Baseline and Month 6 |
| Number of participants with adverse events (AE) | Up to 12 Months |
Countries
China
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed