NCT07824102

Brief Summary

Hormones are chemical messengers that help regulate many functions in the body. As women go through menopause, and as men age, levels of certain reproductive hormones change significantly. One of these hormones, luteinizing hormone (LH), increases substantially after menopause and may also rise in some men. Another hormone, human chorionic gonadotropin (hCG), is best known as the hormone of pregnancy, but small amounts can also be detected in some postmenopausal women and older men. Recent research suggests that LH and hCG may have effects beyond reproduction. These hormones may influence bone health, body weight, kidney function, thyroid function, and adrenal gland function. However, little is known about their importance in patients with endocrine disorders. The purpose of this study is to investigate whether blood levels of LH and hCG are associated with the presence, severity, and long-term outcomes of endocrine diseases. The study will include adult patients undergoing evaluation for hormonal disorders. Blood samples will be analyzed for LH, hCG, and other relevant hormones and biomarkers. Participants will also be followed through national health registries to examine whether these hormone levels are associated with future health outcomes. The results of this study may improve our understanding of how LH and hCG affect the body and help determine whether these hormones can be used as biomarkers to improve the diagnosis and management of endocrine diseases.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
233mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jan 2026Dec 2045

Study Start

First participant enrolled

January 1, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
19.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2045

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2045

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

19.9 years

First QC Date

September 11, 2026

Last Update Submit

September 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Association between serum LH and hCG and risk of major osteoporotic fracture (MOF)

    Among patients with suspected or confirmed osteoporosis

    From baseline up to 5-, 10-, and 15-year follow-up

Secondary Outcomes (7)

  • Association between serum LH and hCG and risk of later diagnosis of osteoporosis

    From baseline up to 5-, 10-, and 15-year follow-up

  • Association between serum LH and hCG and urinary calcium/phosphate ratio

    Baseline association

  • Association between serum LH and hCG and serum T4/T3 ratio

    Baseline association

  • Association between serum LH and hCG and risk of T3 treatment initiation

    From baseline up to 5-, 10-, and 15-year follow-up

  • Association between serum LH and hCG and risk malignant adrenal tumor

    From baseline up to 5-, 10-, and 15-year follow-up

  • +2 more secondary outcomes

Study Arms (5)

Patients with presumed osteoporosis

Patients with presumed Hypercalcemia / Primary Hyperparathyroidism

Patients with presumed thyroidal illness

Patients with presumed adrenal disease

Patients with presumed pituitary disease

Eligibility Criteria

Age18 Years - 90 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsCisgender men and women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients referred or followed at the Department of Endocrinology and Internal Medicine, Herlev Hospital for suspected or confirmed: Osteoporosis, Hypercalcemia/PHPT, thyroid disease, adrenal disease, pituitary disease.

You may qualify if:

  • Patients referred to or patients actively followed at the Department of Endocrinology and Internal Medicine at Herlev Hospital
  • Age 18-90

You may not qualify if:

  • Lacking mental capacity to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology and Internal Medicine, Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

Related Publications (43)

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    PMID: 34612843BACKGROUND
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Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and Urine

MeSH Terms

Conditions

OsteoporosisHypercalcemiaHyperparathyroidism, PrimaryAdrenal Gland DiseasesPituitary DiseasesThyroid Diseases

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersWater-Electrolyte ImbalanceHyperparathyroidismParathyroid DiseasesEndocrine System DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Martin B Jensen, Professor

CONTACT

Mads J Jorsal, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 17, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2045

Study Completion (Estimated)

December 1, 2045

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations