OsteoporosisPhase 4NCT06332014
Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China
A Phase 4 study testing Prolia in people with Osteoporosis, run by Amgen at 16 sites in China.
Trial summary
The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months. Read more about this study
- Who is it for?
- Ages 30 to 90 years, men only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Prolia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 16 sitesChina
- Study dates
- 6 Aug 2024to 23 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510120
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, 510515
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Huaian First Peoples Hospital
Huaian, Jiangsu, 223300
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Jiangxi Provincial Peoples Hospital
Nanchang, Jiangxi, 330038
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Pingxiang Peoples Hospital
Pingxiang, Jiangxi, 337000
Shanghai Sixth Peoples Hospital
Shanghai, 200233
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
The First Peoples Hospital of Kunshan
Suzhou, Jiangsu, 215300
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221002
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
About this study
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
The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months.
- Conditions
- Osteoporosis
- Being tested
- Prolia
- Keywords
- Prolia, Denosumab, AMG 162, Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProliaDrug
Also called Denosumab
Partcipants will receive subcutaneous (SC) injections of Prolia Q6M.
| Study group | Role | What they receive |
|---|---|---|
| Prolia | Experimental | Participants will receive Prolia every six months (Q6M) Receives: Drug: Prolia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12
Measured: Baseline and Month 12
Secondary outcomes (5)
Percent change from baseline in serum C-terminal telopeptide (CTx) at month 3, 6, 9, and 12
Measured: 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
Measured: Baseline and Months 3, 6, 9, and 12
Percent change from baseline in total hip and femoral neck BMD at month 6 and 12
Measured: Baseline and Months 6 and 12
Percent change from baseline in lumbar spine BMD at month 6
Measured: Baseline and Month 6
Number of participants with adverse events (AE)
Measured: Up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start6 Aug 2024
- Primary completion23 Jan 2027 (estimated)
- Study completion23 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332014
- Sponsor's protocol ID
- 20210123
- Status last verified
- Feb 2026
- First submitted
- 19 Mar 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06332014
- Acronym / sponsor ID
- 20210123
- Conditions
- Osteoporosis
- Keywords
- Prolia, Denosumab, AMG 162, Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 23 Jan 2027 (estimated)
- Study completion
- 23 Jan 2027 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolia | Experimental | Drug: ProliaParticipants will receive Prolia every six months (Q6M) |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProliaAlso: DenosumabPartcipants will receive subcutaneous (SC) injections of Prolia Q6M. | Drug | Prolia |
Primary outcome
Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12
Time frame: Baseline and Month 12
5 secondary outcomes
Percent change from baseline in serum C-terminal telopeptide (CTx) at month 3, 6, 9, and 12
Time frame: 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
Time frame: Baseline and Months 3, 6, 9, and 12
Percent change from baseline in total hip and femoral neck BMD at month 6 and 12
Time frame: Baseline and Months 6 and 12
Percent change from baseline in lumbar spine BMD at month 6
Time frame: Baseline and Month 6
Number of participants with adverse events (AE)
Time frame: Up to 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prolia in people with Osteoporosis, run by Amgen at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12 (time frame: Baseline and Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.