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Bone drug boosts sperm in infertile men?

NCT ID NCT06300229

Disease control Sponsor: Martin Blomberg Jensen Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested if denosumab, a drug usually used for bone loss, can improve sperm quality in men with very low sperm counts. 42 infertile men with a specific blood marker took part. The goal was to see if sperm concentration increased after 80 days of treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

42 people

The number who actually took part.

Started

Mar 2024

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infertile men ≥ 18 years and \< 60 years of age * Sperm concentration ≤ 2 million pr. mL * Serum AMH levels ≥28 pmol/L. * The participants must have appropriate Danish or English language skills and give written informed consent. Exclusion Criteria: * Chronic diseases, defined as diagnosis where signs, symptoms, and treatment imply an expected long duration and lack of a cure, such as diabetes mellitus, metabolism disorders, osteoporosis, colitis, etc. * Sperm concentration \<0.01 million pr. mL * Men with current or previous malignancies, or at potential risk of testicular cancer after baseline examination and ultrasound will be excluded. * Men with hypocalcemia at baseline, defined as albumin corrected calcium \< 2,17 mmol/L or total calcium \< 2.14 mmol/L * Serum vitamin D (25OHD) levels \< 25 nmol/L * estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1,73 m2 * Insufficient dental status * Vasectomy * Hypersensitivity to latex, Denosumab, or to any of the excipients (acetic acid, sodium hydroxide, Sorbitol (E420), Polysorbate 20) will be excluded. * Serum FSH \<3 IU/L * Testis size \> 17 mL * BMI ≥ 35 kg/m2

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Conditions

The condition(s) this trial relates to.

male infertility

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infertility, male

Contacts and locations

Locations

  • Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine

    Copenhagen, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.