Clinical trial NCT06332014: Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China
Official title: A Phase 4 Single Arm Open Label Study for the Efficacy and Safety of Prolia in Treatment of Male Subjects With Osteoporosis in Mainland China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Osteoporosis
Keywords: Prolia
Denosumab
AMG 162
Osteoporosis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-03-26
Enrollment: 100
Sex: MALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Percent change from baseline in serum C-terminal telopeptide (CTx) at month 3, 6, 9, and 12
timeFrame: Baseline and Months 3, 6, 9, and 12
measure: Percent change from baseline in serum procollagen Type 1 N-Telopeptide (P1NP) at month 3, 6, 9, and 12
timeFrame: Baseline and Months 3, 6, 9, and 12
measure: Percent change from baseline in total hip and femoral neck BMD at month 6 and 12
timeFrame: Baseline and Months 6 and 12
measure: Percent change from baseline in lumbar spine BMD at month 6
timeFrame: Baseline and Month 6
measure: Number of participants with adverse events (AE)
timeFrame: Up to 12 Months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital Southern Medical University
state: Guangdong
city: Harbin
country: China
facility: The Fourth Hospital of Harbin Medical University
state: Heilongjiang
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Peoples Hospital
state: Jiangxi
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Sixth Peoples Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: