Denosumab and male infertility: A study to investigate how denosumab will influence male reproductive function

Denosumab and male infertility: a prospective intervention study - denosumab and male infertility

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000655-24-DK

Enrollment

Unknown

Registered

2015-04-28

Start date

2015-04-28

Completion date

Unknown

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male infertility especially low sperm count MedDRA version: 18.0 Level: PT Classification code 10021929 Term: Infertility male System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Prolia (Denosumab) Product Name: Prolia Product Code: 9001231 Pharmaceutical Form: Injection INN or Proposed INN: Denosumab CAS Number: 615258-40-7 Current Sponsor code: Prolia Other descr

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: men > 18 years with male infertility sperm concentration > 0.100 million/ml 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 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: men with chronical illness and serious co-morbidities in need of treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: to investigate whteher short term Denosumab treatment can imporve sperm count and male fertility;Secondary Objective: change in semen quality change in Inhibin B change in sexhormones or gonadotropins change in BMD Change in vitamin d metabolites change in endocrine bone factors change in ART change in sperm positive for CYP24A1 Change in DFI change in concentraion of bone markers in spermaplasma ;Primary end point(s): change in the number of total sperm and sperm concentration;Timepoint(s) of evaluation of this end point: after 5 days, 2 weeks, 6 weeks, and then monthly until 6 months after inclusion.	—

Measure

Time frame

Main Objective: to investigate whteher short term Denosumab treatment can imporve sperm count and male fertility;Secondary Objective: change in semen quality change in Inhibin B change in sexhormones or gonadotropins change in BMD Change in vitamin d metabolites change in endocrine bone factors change in ART change in sperm positive for CYP24A1 Change in DFI change in concentraion of bone markers in spermaplasma ;Primary end point(s): change in the number of total sperm and sperm concentration;Timepoint(s) of evaluation of this end point: after 5 days, 2 weeks, 6 weeks, and then monthly until 6 months after inclusion.

—

Secondary

Measure	Time frame
Secondary end point(s): change in semen quality change in Inhibin B change in sexhormones or gonadotropins change in BMD Change in vitamin d metabolites change in endocrine bone factors change in ART;Timepoint(s) of evaluation of this end point: after 5 days, 2 weeks, 6 weeks, and then monthly until 6 months after inclusion.	—

Countries

Denmark

Contacts

Public Contactmartin blomberg jensen

rigshospitalet

blombergjensen@gmail.com4535451865

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026