OsteoporosisNCT07824102
Evaluation of the Role of Luteinizing Hormone (LH) and Human Chorionic Gonadotropin (hCG) in Adult Patients Undergoing Assessment for Endocrine Disorders
An observational study of Osteoporosis and Hypercalcemia, run by Martin Blomberg Jensen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoporosis, Hypercalcemia, Primary Hyperparathyroidism
- How many people
- 20,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2026to Dec 2045
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients referred to or patients actively followed at the Department of Endocrinology and Internal Medicine at Herlev Hospital
- Age 18-90
Who cannot join
- Lacking mental capacity to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mads J Jorsal, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Endocrinology and Internal Medicine, Herlev Hospital
Herlev, 2730
Mads J Jorsal, MD, mads.joon.jorsal@regionh.dk
Emil B Wriedt, MD, emil.brink.wriedt@regionh.dk
About this study
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.
Read more
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.
Read the detailed description
The hormonal changes that occur during the menopausal transition and after menopause affect multiple organ systems and are associated with a range of symptoms and chronic diseases. The prevalence of several endocrine disorders, including hypothyroidism, primary hyperparathyroidism, osteoporosis, and adrenal tumors, increases markedly during and after menopause. In addition, postmenopausal women are at increased risk of obesity, type 2 diabetes, hypertension, cardiovascular disease, and osteoporosis. While menopausal hormone therapy can alleviate symptoms and reduce bone loss, concerns regarding breast cancer and thromboembolic risk limit its use, highlighting the need for a better understanding of the biological mechanisms underlying menopausal symptoms and long-term health complications.
Menopause is characterized not only by declining estrogen concentrations but also by a marked increase in circulating luteinizing hormone (LH). Most metabolic and skeletal changes associated with menopause have traditionally been attributed to estrogen deficiency. However, several important changes, including accelerated bone loss and weight gain, often begin during perimenopause when estrogen concentrations remain relatively stable but LH levels increase substantially. This observation suggests that elevated LH may have physiological effects beyond its established role in the reproductive system.
LH exerts its biological effects through the luteinizing hormone/choriogonadotropin receptor (LHCGR), which is also activated by human chorionic gonadotropin (hCG). Although hCG is generally considered a pregnancy-associated hormone, measurable concentrations are frequently observed in postmenopausal women and in men with hypergonadotropic hypogonadism. Emerging evidence from our group suggests that LH and hCG have previously unrecognized effects on calcium homeostasis, adipose tissue, thyroid hormone metabolism, adrenal function, and potentially the development and progression of endocrine diseases.
Experimental and clinical studies conducted by our group indicate that LH and hCG stimulate urinary calcium excretion, leading to compensatory increases in parathyroid hormone (PTH) and increased bone resorption. These findings suggest the existence of a novel physiological interaction between the hypothalamic-pituitary-gonadal axis and mineral metabolism. Such mechanisms may contribute to osteoporosis development and other disorders of calcium homeostasis, particularly in postmenopausal women exposed to prolonged elevations in LH.
In addition to skeletal effects, our data indicate that adipose tissue expresses LHCGR and responds directly to LH stimulation. Elevated LH levels may influence adipocyte function, brown adipose tissue activity, energy expenditure, weight regulation, and thyroid hormone activation through inhibition of type II iodothyronine deiodinase (DIO2). These findings suggest that LH may contribute to metabolic alterations associated with aging and menopause.
Furthermore, LHCGR expression has been identified in the adrenal gland and in a substantial proportion of benign adrenal tumors. Preliminary clinical and experimental findings indicate that LH may influence adrenal steroidogenesis and could be involved in the pathophysiology of adrenal incidentalomas, including mild autonomous cortisol secretion (MACS). Elevated LH concentrations may therefore represent a novel biomarker for adrenal dysfunction and disease progression.
Recent epidemiological evidence also suggests that elevated LH and altered testosterone-to-LH ratios are associated with increased mortality risk. Collectively, these observations support the hypothesis that LH and hCG function as systemic endocrine regulators with biological effects extending well beyond the gonads.
To further investigate this concept, we propose a prospective observational study of adult patients referred for endocrine evaluation. The study will systematically assess circulating concentrations of LH, follicle-stimulating hormone (FSH), and hCG and examine their associations with endocrine disease severity, biochemical phenotypes, and long-term clinical outcomes through linkage with national health registries. The overarching aim is to determine whether LH and hCG can serve as clinically useful biomarkers and contributors to disease mechanisms across multiple endocrine disorders.
- Conditions
- Osteoporosis, Hypercalcemia, Primary Hyperparathyroidism, Adrenal Gland Disease, Pituitary Disease, Thyroid Diseases
- Medical subject headings
- Osteoporosis, Hypercalcemia, Hyperparathyroidism, Primary, Adrenal Gland Diseases, Pituitary Diseases, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with presumed osteoporosis | Not described | |
| Patients with presumed Hypercalcemia / Primary Hyperparathyroidism | Not described | |
| Patients with presumed thyroidal illness | Not described | |
| Patients with presumed adrenal disease | Not described | |
| Patients with presumed pituitary disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between serum LH and hCG and risk of major osteoporotic fracture (MOF)
Among patients with suspected or confirmed osteoporosis
Measured: 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
Among patients with suspected or confirmed hypercalcemia/primary hyperparathyroidism
Measured: From baseline up to 5-, 10-, and 15-year follow-up
Association between serum LH and hCG and urinary calcium/phosphate ratio
Among patients with suspected or confirmed hypercalcemia/primary hyperparathyroidism
Measured: Baseline association
Association between serum LH and hCG and serum T4/T3 ratio
Among patients with suspected or confirmed thyroid disease
Measured: Baseline association
Association between serum LH and hCG and risk of T3 treatment initiation
Among patients with suspected or confirmed thyroid disease
Measured: From baseline up to 5-, 10-, and 15-year follow-up
Association between serum LH and hCG and risk malignant adrenal tumor
Among patients with suspected or confirmed adrenal disease
Measured: From baseline up to 5-, 10-, and 15-year follow-up
Association between serum LH and hCG and risk of primary hyperaldosteronism
Among patients with suspected or confirmed adrenal disease
Measured: From baseline up to 5-, 10-, and 15-year follow-up
Association between serum LH and hCG and risk of mild autonomous cortisol secretion
Among patients with suspected or confirmed adrenal disease
Measured: From baseline up to 5-, 10-, 15-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Jan 2026
- Primary completionDec 2045 (estimated)
- Study completionDec 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin Blomberg Jensen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev
- Responsible party
- Sponsor-investigator, Martin Blomberg Jensen, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824102
- Sponsor's protocol ID
- H-24076355
- Other IDs
- H-24076355
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Hage L, Hatipoglu B. Elevated hCG can be a benign finding in perimenopausal and postmenopausal women. Cleve Clin J Med. 2021 Nov 2;88(11):635-639. doi: 10.3949/ccjm.88a.18069.
PubMed 34728490Bone HG, Wagman RB, Brandi ML, Brown JP, Chapurlat R, Cummings SR, Czerwinski E, Fahrleitner-Pammer A, Kendler DL, Lippuner K, Reginster JY, Roux C, Malouf J, Bradley MN, Daizadeh NS, Wang A, Dakin P, Pannacciulli N, Dempster DW, Papapoulos S. 10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension. Lancet Diabetes Endocrinol. 2017 Jul;5(7):513-523. doi: 10.1016/S2213-8587(17)30138-9. Epub 2017 May 22.
PubMed 28546097Childs AJ, Cowan G, Kinnell HL, Anderson RA, Saunders PT. Retinoic Acid signalling and the control of meiotic entry in the human fetal gonad. PLoS One. 2011;6(6):e20249. doi: 10.1371/journal.pone.0020249. Epub 2011 Jun 3.
PubMed 21674038Le Bouffant R, Guerquin MJ, Duquenne C, Frydman N, Coffigny H, Rouiller-Fabre V, Frydman R, Habert R, Livera G. Meiosis initiation in the human ovary requires intrinsic retinoic acid synthesis. Hum Reprod. 2010 Oct;25(10):2579-90. doi: 10.1093/humrep/deq195. Epub 2010 Jul 29.
PubMed 20670969Lambrot R, Coffigny H, Pairault C, Donnadieu AC, Frydman R, Habert R, Rouiller-Fabre V. Use of organ culture to study the human fetal testis development: effect of retinoic acid. J Clin Endocrinol Metab. 2006 Jul;91(7):2696-703. doi: 10.1210/jc.2005-2113. Epub 2006 Apr 18.
PubMed 16621909Jorgensen A, Young J, Nielsen JE, Joensen UN, Toft BG, Rajpert-De Meyts E, Loveland KL. Hanging drop cultures of human testis and testis cancer samples: a model used to investigate activin treatment effects in a preserved niche. Br J Cancer. 2014 May 13;110(10):2604-14. doi: 10.1038/bjc.2014.160. Epub 2014 Apr 29.
PubMed 24781282Nikitin AV, Makarovskaia LN, Fomina IP, Ivanitskaia LP, Popova GO, Vinidchenko NN, Korganov IaN, Gorin SE. [Multifactorial experiment on the combined effect of rifampicin and microbial polysaccharide in experimental plague infection]. Antibiot Khimioter. 1991 May;36(5):25-7. Russian.
PubMed 1953167Holt R, Yahyavi SK, Kooij I, Poulsen NN, Juul A, Jorgensen N, Blomberg Jensen M. Effects of vitamin D on sex steroids, luteinizing hormone, and testosterone to luteinizing hormone ratio in 307 infertile men. Andrology. 2024 Mar;12(3):553-560. doi: 10.1111/andr.13505. Epub 2023 Aug 9.
PubMed 37555466Prete A, Bancos I. Mild autonomous cortisol secretion: pathophysiology, comorbidities and management approaches. Nat Rev Endocrinol. 2024 Aug;20(8):460-473. doi: 10.1038/s41574-024-00984-y. Epub 2024 Apr 22.
PubMed 38649778Kero JT, Savontaus E, Mikola M, Pesonen U, Koulu M, Keri RA, Nilson JH, Poutanen M, Huhtaniemi IT. Obesity in transgenic female mice with constitutively elevated luteinizing hormone secretion. Am J Physiol Endocrinol Metab. 2003 Oct;285(4):E812-8. doi: 10.1152/ajpendo.00367.2002. Epub 2003 May 28.
PubMed 12773309Neff LM, Hoffmann ME, Zeiss DM, Lowry K, Edwards M, Rodriguez SM, Wachsberg KN, Kushner R, Landsberg L. Core body temperature is lower in postmenopausal women than premenopausal women: potential implications for energy metabolism and midlife weight gain. Cardiovasc Endocrinol. 2016 Dec;5(4):151-154. doi: 10.1097/XCE.0000000000000078.
PubMed 28111609Kaikaew K, Grefhorst A, Visser JA. Sex Differences in Brown Adipose Tissue Function: Sex Hormones, Glucocorticoids, and Their Crosstalk. Front Endocrinol (Lausanne). 2021 Apr 13;12:652444. doi: 10.3389/fendo.2021.652444. eCollection 2021.
PubMed 33927694Wells L, Vosseller K, Hart GW. A role for N-acetylglucosamine as a nutrient sensor and mediator of insulin resistance. Cell Mol Life Sci. 2003 Feb;60(2):222-8. doi: 10.1007/s000180300017.
PubMed 12678487Chatham JC, Zhang J, Wende AR. Role of O-Linked N-Acetylglucosamine Protein Modification in Cellular (Patho)Physiology. Physiol Rev. 2021 Apr 1;101(2):427-493. doi: 10.1152/physrev.00043.2019. Epub 2020 Jul 30.
PubMed 32730113Blomberg Jensen M, Andreassen CH, Jorgensen A, Nielsen JE, Juel Mortensen L, Boisen IM, Schwarz P, Toppari J, Baron R, Lanske B, Juul A. RANKL regulates male reproductive function. Nat Commun. 2021 Apr 23;12(1):2450. doi: 10.1038/s41467-021-22734-8.
PubMed 33893301
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Luteinizing Hormone (LH) and Human Chorionic Gonadotropin (hCG) in Adult Patients Undergoing Assessment for Endocrine Disorders
- ClinicalTrials.gov ID
- NCT07824102
- Acronym / sponsor ID
- H-24076355
- Conditions
- Osteoporosis, Hypercalcemia, Primary Hyperparathyroidism, Adrenal Gland Disease, Pituitary Disease, Thyroid Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Martin Blomberg JensenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Dec 2045 (estimated)
- Study completion
- Dec 2045 (estimated)
- First posted
- 17 Sep 2026 (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.
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.
Detailed description
The hormonal changes that occur during the menopausal transition and after menopause affect multiple organ systems and are associated with a range of symptoms and chronic diseases. The prevalence of several endocrine disorders, including hypothyroidism, primary hyperparathyroidism, osteoporosis, and adrenal tumors, increases markedly during and after menopause. In addition, postmenopausal women are at increased risk of obesity, type 2 diabetes, hypertension, cardiovascular disease, and osteoporosis. While menopausal hormone therapy can alleviate symptoms and reduce bone loss, concerns regarding breast cancer and thromboembolic risk limit its use, highlighting the need for a better understanding of the biological mechanisms underlying menopausal symptoms and long-term health complications.
Menopause is characterized not only by declining estrogen concentrations but also by a marked increase in circulating luteinizing hormone (LH). Most metabolic and skeletal changes associated with menopause have traditionally been attributed to estrogen deficiency. However, several important changes, including accelerated bone loss and weight gain, often begin during perimenopause when estrogen concentrations remain relatively stable but LH levels increase substantially. This observation suggests that elevated LH may have physiological effects beyond its established role in the reproductive system.
LH exerts its biological effects through the luteinizing hormone/choriogonadotropin receptor (LHCGR), which is also activated by human chorionic gonadotropin (hCG). Although hCG is generally considered a pregnancy-associated hormone, measurable concentrations are frequently observed in postmenopausal women and in men with hypergonadotropic hypogonadism. Emerging evidence from our group suggests that LH and hCG have previously unrecognized effects on calcium homeostasis, adipose tissue, thyroid hormone metabolism, adrenal function, and potentially the development and progression of endocrine diseases.
Experimental and clinical studies conducted by our group indicate that LH and hCG stimulate urinary calcium excretion, leading to compensatory increases in parathyroid hormone (PTH) and increased bone resorption. These findings suggest the existence of a novel physiological interaction between the hypothalamic-pituitary-gonadal axis and mineral metabolism. Such mechanisms may contribute to osteoporosis development and other disorders of calcium homeostasis, particularly in postmenopausal women exposed to prolonged elevations in LH.
In addition to skeletal effects, our data indicate that adipose tissue expresses LHCGR and responds directly to LH stimulation. Elevated LH levels may influence adipocyte function, brown adipose tissue activity, energy expenditure, weight regulation, and thyroid hormone activation through inhibition of type II iodothyronine deiodinase (DIO2). These findings suggest that LH may contribute to metabolic alterations associated with aging and menopause.
Furthermore, LHCGR expression has been identified in the adrenal gland and in a substantial proportion of benign adrenal tumors. Preliminary clinical and experimental findings indicate that LH may influence adrenal steroidogenesis and could be involved in the pathophysiology of adrenal incidentalomas, including mild autonomous cortisol secretion (MACS). Elevated LH concentrations may therefore represent a novel biomarker for adrenal dysfunction and disease progression.
Recent epidemiological evidence also suggests that elevated LH and altered testosterone-to-LH ratios are associated with increased mortality risk. Collectively, these observations support the hypothesis that LH and hCG function as systemic endocrine regulators with biological effects extending well beyond the gonads.
To further investigate this concept, we propose a prospective observational study of adult patients referred for endocrine evaluation. The study will systematically assess circulating concentrations of LH, follicle-stimulating hormone (FSH), and hCG and examine their associations with endocrine disease severity, biochemical phenotypes, and long-term clinical outcomes through linkage with national health registries. The overarching aim is to determine whether LH and hCG can serve as clinically useful biomarkers and contributors to disease mechanisms across multiple endocrine disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients referred to or patients actively followed at the Department of Endocrinology and Internal Medicine at Herlev Hospital
- Age 18-90
Key exclusion criteria (1 listed)
- Lacking mental capacity to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between serum LH and hCG and risk of major osteoporotic fracture (MOF)
Time frame: From baseline up to 5-, 10-, and 15-year follow-up
Among patients with suspected or confirmed osteoporosis
7 secondary outcomes
Association between serum LH and hCG and risk of later diagnosis of osteoporosis
Time frame: From baseline up to 5-, 10-, and 15-year follow-up
Association between serum LH and hCG and urinary calcium/phosphate ratio
Time frame: Baseline association
Association between serum LH and hCG and serum T4/T3 ratio
Time frame: Baseline association
Association between serum LH and hCG and risk of T3 treatment initiation
Time frame: From baseline up to 5-, 10-, and 15-year follow-up
Association between serum LH and hCG and risk malignant adrenal tumor
Time frame: From baseline up to 5-, 10-, and 15-year follow-up
Association between serum LH and hCG and risk of primary hyperaldosteronism
Time frame: From baseline up to 5-, 10-, and 15-year follow-up
Association between serum LH and hCG and risk of mild autonomous cortisol secretion
Time frame: From baseline up to 5-, 10-, 15-year follow-up
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 17 Sep 2026.
- Background: PubMed 34728490El Hage L, Hatipoglu B. Elevated hCG can be a benign finding in perimenopausal and postmenopausal women. Cleve Clin J Med. 2021 Nov 2;88(11):635-639. doi: 10.3949/ccjm.88a.18069.
- Background: PubMed 28546097Bone HG, Wagman RB, Brandi ML, Brown JP, Chapurlat R, Cummings SR, Czerwinski E, Fahrleitner-Pammer A, Kendler DL, Lippuner K, Reginster JY, Roux C, Malouf J, Bradley MN, Daizadeh NS, Wang A, Dakin P, Pannacciulli N, Dempster DW, Papapoulos S. 10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension. Lancet Diabetes Endocrinol. 2017 Jul;5(7):513-523. doi: 10.1016/S2213-8587(17)30138-9. Epub 2017 May 22.
- Background: PubMed 21674038Childs AJ, Cowan G, Kinnell HL, Anderson RA, Saunders PT. Retinoic Acid signalling and the control of meiotic entry in the human fetal gonad. PLoS One. 2011;6(6):e20249. doi: 10.1371/journal.pone.0020249. Epub 2011 Jun 3.
- Background: PubMed 20670969Le Bouffant R, Guerquin MJ, Duquenne C, Frydman N, Coffigny H, Rouiller-Fabre V, Frydman R, Habert R, Livera G. Meiosis initiation in the human ovary requires intrinsic retinoic acid synthesis. Hum Reprod. 2010 Oct;25(10):2579-90. doi: 10.1093/humrep/deq195. Epub 2010 Jul 29.
- Background: PubMed 16621909Lambrot R, Coffigny H, Pairault C, Donnadieu AC, Frydman R, Habert R, Rouiller-Fabre V. Use of organ culture to study the human fetal testis development: effect of retinoic acid. J Clin Endocrinol Metab. 2006 Jul;91(7):2696-703. doi: 10.1210/jc.2005-2113. Epub 2006 Apr 18.
- Background: PubMed 24781282Jorgensen A, Young J, Nielsen JE, Joensen UN, Toft BG, Rajpert-De Meyts E, Loveland KL. Hanging drop cultures of human testis and testis cancer samples: a model used to investigate activin treatment effects in a preserved niche. Br J Cancer. 2014 May 13;110(10):2604-14. doi: 10.1038/bjc.2014.160. Epub 2014 Apr 29.
- Background: PubMed 1953167Nikitin AV, Makarovskaia LN, Fomina IP, Ivanitskaia LP, Popova GO, Vinidchenko NN, Korganov IaN, Gorin SE. [Multifactorial experiment on the combined effect of rifampicin and microbial polysaccharide in experimental plague infection]. Antibiot Khimioter. 1991 May;36(5):25-7. Russian.
- Background: PubMed 37555466Holt R, Yahyavi SK, Kooij I, Poulsen NN, Juul A, Jorgensen N, Blomberg Jensen M. Effects of vitamin D on sex steroids, luteinizing hormone, and testosterone to luteinizing hormone ratio in 307 infertile men. Andrology. 2024 Mar;12(3):553-560. doi: 10.1111/andr.13505. Epub 2023 Aug 9.
- Background: PubMed 38649778Prete A, Bancos I. Mild autonomous cortisol secretion: pathophysiology, comorbidities and management approaches. Nat Rev Endocrinol. 2024 Aug;20(8):460-473. doi: 10.1038/s41574-024-00984-y. Epub 2024 Apr 22.
- Background: PubMed 12773309Kero JT, Savontaus E, Mikola M, Pesonen U, Koulu M, Keri RA, Nilson JH, Poutanen M, Huhtaniemi IT. Obesity in transgenic female mice with constitutively elevated luteinizing hormone secretion. Am J Physiol Endocrinol Metab. 2003 Oct;285(4):E812-8. doi: 10.1152/ajpendo.00367.2002. Epub 2003 May 28.
- Background: PubMed 28111609Neff LM, Hoffmann ME, Zeiss DM, Lowry K, Edwards M, Rodriguez SM, Wachsberg KN, Kushner R, Landsberg L. Core body temperature is lower in postmenopausal women than premenopausal women: potential implications for energy metabolism and midlife weight gain. Cardiovasc Endocrinol. 2016 Dec;5(4):151-154. doi: 10.1097/XCE.0000000000000078.
- Background: PubMed 33927694Kaikaew K, Grefhorst A, Visser JA. Sex Differences in Brown Adipose Tissue Function: Sex Hormones, Glucocorticoids, and Their Crosstalk. Front Endocrinol (Lausanne). 2021 Apr 13;12:652444. doi: 10.3389/fendo.2021.652444. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Mads J Jorsal, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Hypercalcemia, run by Martin Blomberg Jensen at 1 site in Denmark.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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.
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?
Contact Martin B Jensen, Professor (+4538687318, martin.blomberg.jensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between serum LH and hCG and risk of major osteoporotic fracture (MOF) (time frame: From baseline up to 5-, 10-, and 15-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07824102, which also lists 43 linked publications.
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 17 Sep 2026.