The effect of combination of testosterone and vitamin D on bone mineral density

The effect of combination of testosterone and vitamin D on bone mineral density in patients with testosterone deficiency and vitamin D insufficiency

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0011855

Enrollment

Registered

2026-04-15

Start date

2026-08-03

Completion date

Unknown

Last updated

2026-04-20

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

Conditions

None listed

Interventions

Drug : Investigational Products and Treatment Allocation Drug 1: Testosterone undecanoate Dose: 1000 mg Route and frequency: Intramuscular injection once every 12 weeks, for a total of four administr

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Married men aged 40 years or older who have undergone a routine health screening examination. A hip bone mineral density (BMD) T-score of = -1.0. Serum total testosterone level < 3.5 ng/mL on blood testing. Serum 25-hydroxyvitamin D [25(OH)D] level < 32 ng/mL.

Exclusion criteria

Exclusion criteria: Patients who have received chemotherapy or radiotherapy for cancer within the past 12 months. Patients who have received testosterone replacement therapy within the past 12 months. Patients who have received androgen deprivation therapy within the past 12 months. Suspected hyperparathyroidism, defined as a parathyroid hormone (PTH) level > 100 pg/mL. Serum prostate-specific antigen (PSA) level = 4.0 ng/mL. Subjects with current plans for family planning. Hematocrit level = 48%. History of cardiovascular-related procedures within the past 6 months (e.g., coronary artery stent placement, pacemaker implantation). Presence of heart failure classified as New York Heart Association (NYHA) class II or higher, defined as mild dyspnea with ordinary physical activity (e.g., climbing two flights of stairs), and/or current use of digoxin. Serum creatinine level = 1.6 mg/dL (corresponding to chronic kidney disease stage G3b or higher).

Design outcomes

Primary

Measure	Time frame
The change of Bone mineral density	—

Secondary

Measure	Time frame
Fracture risk assessment tool;International Prostate Symptom Score;Serum testosterone, PSA, Hematocrit, Calcium, Creatinine, Serum 25(OH) vitamin D;Body composition analysis	—

Countries

Korea, Republic of

Contacts

Public ContactDong Sup Lee

The Catholic University of Korea

bbangbbangi@naver.com+82-31-881-8920

Outcome results