OsteoporosisPhase 4DENMUSINNCT07271771
The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity
A Phase 4 study testing Denosumab and Saline (0.9% NaCl) in people with Osteoporosis, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Denosumab and Saline (0.9% NaCl)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 21 May 2024to 1 Mar 2027
- Phase
- Phase 4
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women (postmenopausal for at least two years)
- Age ≥ 40 years
- BMD T-score ≥ -2.0 (lumbar spine, total hip or femoral neck)
- At least 2 lumbar vertebrae that can be evaluated by dual-energy x-ray absorptiometry (DXA)
- Diabetes Mellitus type 2
- Treatment with metformin as monotherapy
Who cannot join
- Treatment for osteoporosis at any time
- Other antidiabetic medication than metformin
- Low-energy vertebral fractures at any time
- Low-energy hip fracture at any time
- Ongoing treatment with systemic glucocorticoids
- Metabolic bone disease (for example osteogenesis imperfecta, Paget's disease of bone, hyperparathyroidism)
Show all 11Show fewer
- Treatment affecting bone, calcium metabolism or muscle
- Active cancer within the last 5 years with the exception of basal cell skin cancer
- Estimated glomerular filtration rate (eGFR) ≤ 35 mL/min
- Unable to read and understand Danish
- Immobility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
Anne Sophie Sølling, MD, PhD, +45 22 30 05 24, annesoel@rm.dk
About this study
Randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength.
Read the detailed description
Denosumab is an antibody against receptor-activator of nuclear factor kappa-B ligand (RANKL) that prevents recruitment and differentiation of mature osteoclasts. Treatment with denosumab markedly decreases bone resorption, increases bone mineral density (BMD), and reduces the risk of vertebral as well as non-vertebral and hip fractures. Osteoclasts produce dipeptidyl peptidase-4 (DPP-4) that degrades glucagon-like peptide-1 (GLP-1) and GLP-1 stimulates insulin production. In accordance with this, animal models have shown a beneficial effect of denosumab on glucose metabolism. However, data from clinical studies in patients with osteoporosis are limited and the results inconsistent. In a small, randomised trial with 52 healthy postmenopausal women, treatment with denosumab for 12 months reduced DPP-4 and increased GLP-1 compared to placebo but no effect was seen on insulin or fasting glucose levels. In the same publication, the authors conducted a non-randomized, observational study in osteoporotic patients with diabetes mellitus or prediabetes that were treated with either denosumab, bisphosphonates, or calcium + vitamin D at the discretion of their physician. Here, treatment with denosumab significantly reduced fasting glucose after 6 months and HbA1c after 12 months compared to bisphosphonates or calcium + vitamin D. Similar findings were seen in another observational study with 20 patients with diabetes. On the other hand, a post hoc analysis of the FREEDOM trial did not find a general effect of denosumab on fasting glucose in postmenopausal women with self-reported diabetes or prediabetes, but only reported a small decrease in fasting glucose in denosumab treated women with diabetes not treated with antidiabetics. This is in line with three small observational studies, in which no clinically relevant effect of denosumab on fasting glucose, insulin level or homeostatic model assessment for insulin resistance (HOMA-IR) was identified.
Overall, the heterogeneity across the studies is large, most of the trials are observational studies and the results are inconsistent. Therefore, randomized, controlled trials are warranted to further elucidate this.
Denosumab has also been shown to improve muscle strength compared to placebo in animal models, however, data from human studies is limited. In an observational study, denosumab decreased the risk of falls and improved sarcopenia measures in 135 patients with osteoporosis compared to 272 patients treated with alendronate or zoledronate assessed at treatment initiation and after 5 years for denosumab and alendronate and 3 years for zoledronate. All outcome measures worsened one years after denosumab discontinuation. In another prospective observational study with 18 postmenopausal women, denosumab treatment for an average of three years improved appendicular lean mass and handgrip strength compared to treatment with bisphosphates or placebo. This is in line with two additional observational studies, in which denosumab improved muscle strength after 6 - 17 months compared to bisphosphonates or vitamin D.
None of the studies evaluating the effect of denosumab on muscle strength are randomised controlled trials, the outcome measures are different and the follow up visits few. Also, none of the studies controlled for exercise.
The investigators therefore want to conduct a randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength.
- Conditions
- Osteoporosis
- Being tested
- Denosumab, Saline (0.9% NaCl)
- Keywords
- muscle, insulin sensitivity, denosumab, bone mineral density
- Medical subject headings
- Osteoporosis, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Denosumab 60 mg
Saline (0.9% NaCl)Drug
Also called Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | Experimental | Denosumab Receives: Drug: Denosumab |
| Study group 2 | Placebo comparator | Placebo Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity: HbA1c
Changes in Hb1Ac (mmol/mol) from baseline to month 12
Measured: 12 months
Insulin sensitivity: HOMA-IR
Changes in HOMA-IR from baseline to month 12
Measured: 12 months
Insulin sensitivity: fasting glucose
Changes in fasting glucose (mmol/l) from baseline to month 12
Measured: 12 months
Insulin sensitivity: oral glucose tolerance test
Changes in oral glucose tolerance test (OGTT) (mmol/l) from baseline to month 12
Measured: 12 months
Muscle mass
Changes in muscle mass (kg) from baseline to month 12.
Measured: 12 months
Muscle strength
Changes in muscle strength (N) from baseline to month 12.
Measured: 12 months
Secondary outcomes (11)
DPP-4
Changes in DPP-4 (U/L) from baseline to month 12.
Measured: 12 months
GLP-1
Changes in GLP-1 (pmol/L) from baseline to month 12.
Measured: 12 months
Bone turnover markers: CTX
Changes in carboxy-terminal collagen crosslinks (CTX) (ug/l) from baseline to month 12.
Measured: 12 months
Bone turnover markers: PINP
Changes in procollagen type I N-terminal propeptide (PINP) (ug/L) from baseline to month 12.
Measured: 12 months
Bone Mineral Density
Change in lumbar spine BMD (g/cm2) from baseline to month 12.
Measured: 12 months
Advanced glycation end products (AGEs)
Change in advanced glycation end products (AGEs) from baseline to month 12.
Measured: 12 months
Muscle strength
Changes in muscle strength (N) from baseline to month 1 and 3.
Measured: Month 1 and 3
Insulin sensitivity: Hb1Ac month 1 and 3
Changes in Hb1Ac (mmol/mol) from baseline to month 1 and 3
Measured: Month 1 and 3
Insulin sensitivity: HOMA-IR month 1 and 3
Changes in HOMA-IR from baseline to month 1 and 3
Measured: Month 1 and 3
insulin sensitivity: fasting glucose month 1 and 3
Changes in fasting glucose (mmol/l) from baseline to month 1 and 3
Measured: Month 1 and 3
Insulin sensitivity: OGTT month 1 and 3
Changes in oral glucose tolerance test (OGTT) (mmol/l) from baseline to month 1 and 3
Measured: Month 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start21 May 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized double-blind, interventional study in 40 postmenopausal with diabetes mellitus type 2. The patients will be randomized at baseline to denosumab 60 mg (n=20) or placebo (n=20), which will administrated at base-line and month 6.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sponsor: MD, Professor, DMSc, PhD Bente Lomholt Langdahl
- Responsible party
- Principal investigator, Anne Sophie Sølling, Aarhus University Hospital
- Investigators
- Bente Langdahl, MD, Professor, DMSc, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271771
- Sponsor's protocol ID
- CTIS: 2024-510637-18-00
- Other IDs
- CTIS: 2024-510637-18-00
- Acronym
- DENMUSIN
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All results including inconclusive, positive, and negative results will be accessible to the public after the study has ended. As soon as possible and no later than one year after the trial has ended, the trial results will be submitted to the CTIS-portal.
Publications
Anastasilakis AD, Papapoulos SE, Polyzos SA, Appelman-Dijkstra NM, Makras P. Zoledronate for the Prevention of Bone Loss in Women Discontinuing Denosumab Treatment. A Prospective 2-Year Clinical Trial. J Bone Miner Res. 2019 Dec;34(12):2220-2228. doi: 10.1002/jbmr.3853. Epub 2019 Oct 14.
PubMed 31433518Miller PD, Bolognese MA, Lewiecki EM, McClung MR, Ding B, Austin M, Liu Y, San Martin J. Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial. Bone. 2008 Aug;43(2):222-229. doi: 10.1016/j.bone.2008.04.007. Epub 2008 Apr 26.
PubMed 18539106Rupp T, von Vopelius E, Strahl A, Oheim R, Barvencik F, Amling M, Rolvien T. Beneficial effects of denosumab on muscle performance in patients with low BMD: a retrospective, propensity score-matched study. Osteoporos Int. 2022 Oct;33(10):2177-2184. doi: 10.1007/s00198-022-06470-3. Epub 2022 Jun 25.
PubMed 35751664Phu S, Bani Hassan E, Vogrin S, Kirk B, Duque G. Effect of Denosumab on Falls, Muscle Strength, and Function in Community-Dwelling Older Adults. J Am Geriatr Soc. 2019 Dec;67(12):2660-2661. doi: 10.1111/jgs.16165. Epub 2019 Sep 4. No abstract available.
PubMed 31483858Miedany YE, Gaafary ME, Toth M, Hegazi MO, Aroussy NE, Hassan W, Almedany S, Nasr A, Bahlas S, Galal S; Egyptian Academy of Bone Health, Metabolic Bone Diseases. Is there a potential dual effect of denosumab for treatment of osteoporosis and sarcopenia? Clin Rheumatol. 2021 Oct;40(10):4225-4232. doi: 10.1007/s10067-021-05757-w. Epub 2021 May 19.
PubMed 34008069Rossini A, Frigerio S, Dozio E, Trevisan R, Perseghin G, Corbetta S. Effect of Denosumab on Glucose Homeostasis in Postmenopausal Women with Breast Cancer Treated with Aromatase Inhibitors: A Pilot Study. Int J Endocrinol. 2020 Nov 6;2020:1809150. doi: 10.1155/2020/1809150. eCollection 2020.
PubMed 33204260Lasco A, Morabito N, Basile G, Atteritano M, Gaudio A, Giorgianni GM, Morini E, Faraci B, Bellone F, Catalano A. Denosumab Inhibition of RANKL and Insulin Resistance in Postmenopausal Women with Osteoporosis. Calcif Tissue Int. 2016 Feb;98(2):123-8. doi: 10.1007/s00223-015-0075-5. Epub 2015 Oct 24.
PubMed 26498169Passeri E, Benedini S, Costa E, Corbetta S. A Single 60 mg Dose of Denosumab Might Improve Hepatic Insulin Sensitivity in Postmenopausal Nondiabetic Severe Osteoporotic Women. Int J Endocrinol. 2015;2015:352858. doi: 10.1155/2015/352858. Epub 2015 Mar 19.
PubMed 25873952Napoli N, Pannacciulli N, Vittinghoff E, Crittenden D, Yun J, Wang A, Wagman R, Schwartz AV. Effect of denosumab on fasting glucose in women with diabetes or prediabetes from the FREEDOM trial. Diabetes Metab Res Rev. 2018 May;34(4):e2991. doi: 10.1002/dmrr.2991. Epub 2018 Apr 16.
PubMed 29430796Abe I, Ochi K, Takashi Y, Yamao Y, Ohishi H, Fujii H, Minezaki M, Sugimoto K, Kudo T, Abe M, Ohnishi Y, Mukoubara S, Kobayashi K. Effect of denosumab, a human monoclonal antibody of receptor activator of nuclear factor kappa-B ligand (RANKL), upon glycemic and metabolic parameters: Effect of denosumab on glycemic parameters. Medicine (Baltimore). 2019 Nov;98(47):e18067. doi: 10.1097/MD.0000000000018067.
PubMed 31764838Bonnet N, Bourgoin L, Biver E, Douni E, Ferrari S. RANKL inhibition improves muscle strength and insulin sensitivity and restores bone mass. J Clin Invest. 2019 May 23;129(8):3214-3223. doi: 10.1172/JCI125915.
PubMed 31120440Weivoda MM, Chew CK, Monroe DG, Farr JN, Atkinson EJ, Geske JR, Eckhardt B, Thicke B, Ruan M, Tweed AJ, McCready LK, Rizza RA, Matveyenko A, Kassem M, Andersen TL, Vella A, Drake MT, Clarke BL, Oursler MJ, Khosla S. Identification of osteoclast-osteoblast coupling factors in humans reveals links between bone and energy metabolism. Nat Commun. 2020 Jan 7;11(1):87. doi: 10.1038/s41467-019-14003-6.
PubMed 31911667Bone 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 28546097Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 Aug 20;361(8):756-65. doi: 10.1056/NEJMoa0809493. Epub 2009 Aug 11.
PubMed 19671655Lacey DL, Boyle WJ, Simonet WS, Kostenuik PJ, Dougall WC, Sullivan JK, San Martin J, Dansey R. Bench to bedside: elucidation of the OPG-RANK-RANKL pathway and the development of denosumab. Nat Rev Drug Discov. 2012 May;11(5):401-19. doi: 10.1038/nrd3705.
PubMed 22543469
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT07271771
- Acronym / sponsor ID
- DENMUSIN / CTIS: 2024-510637-18-00
- Conditions
- Osteoporosis
- Keywords
- muscle, insulin sensitivity, denosumab, bone mineral density
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Sponsor: MD, Professor, DMSc, PhD Bente Lomholt Langdahl
- Study start
- 21 May 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 9 Dec 2025 (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.
Randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength.
Detailed description
Denosumab is an antibody against receptor-activator of nuclear factor kappa-B ligand (RANKL) that prevents recruitment and differentiation of mature osteoclasts. Treatment with denosumab markedly decreases bone resorption, increases bone mineral density (BMD), and reduces the risk of vertebral as well as non-vertebral and hip fractures. Osteoclasts produce dipeptidyl peptidase-4 (DPP-4) that degrades glucagon-like peptide-1 (GLP-1) and GLP-1 stimulates insulin production. In accordance with this, animal models have shown a beneficial effect of denosumab on glucose metabolism. However, data from clinical studies in patients with osteoporosis are limited and the results inconsistent. In a small, randomised trial with 52 healthy postmenopausal women, treatment with denosumab for 12 months reduced DPP-4 and increased GLP-1 compared to placebo but no effect was seen on insulin or fasting glucose levels. In the same publication, the authors conducted a non-randomized, observational study in osteoporotic patients with diabetes mellitus or prediabetes that were treated with either denosumab, bisphosphonates, or calcium + vitamin D at the discretion of their physician. Here, treatment with denosumab significantly reduced fasting glucose after 6 months and HbA1c after 12 months compared to bisphosphonates or calcium + vitamin D. Similar findings were seen in another observational study with 20 patients with diabetes. On the other hand, a post hoc analysis of the FREEDOM trial did not find a general effect of denosumab on fasting glucose in postmenopausal women with self-reported diabetes or prediabetes, but only reported a small decrease in fasting glucose in denosumab treated women with diabetes not treated with antidiabetics. This is in line with three small observational studies, in which no clinically relevant effect of denosumab on fasting glucose, insulin level or homeostatic model assessment for insulin resistance (HOMA-IR) was identified.
Overall, the heterogeneity across the studies is large, most of the trials are observational studies and the results are inconsistent. Therefore, randomized, controlled trials are warranted to further elucidate this.
Denosumab has also been shown to improve muscle strength compared to placebo in animal models, however, data from human studies is limited. In an observational study, denosumab decreased the risk of falls and improved sarcopenia measures in 135 patients with osteoporosis compared to 272 patients treated with alendronate or zoledronate assessed at treatment initiation and after 5 years for denosumab and alendronate and 3 years for zoledronate. All outcome measures worsened one years after denosumab discontinuation. In another prospective observational study with 18 postmenopausal women, denosumab treatment for an average of three years improved appendicular lean mass and handgrip strength compared to treatment with bisphosphates or placebo. This is in line with two additional observational studies, in which denosumab improved muscle strength after 6 - 17 months compared to bisphosphonates or vitamin D.
None of the studies evaluating the effect of denosumab on muscle strength are randomised controlled trials, the outcome measures are different and the follow up visits few. Also, none of the studies controlled for exercise.
The investigators therefore want to conduct a randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a randomized double-blind, interventional study in 40 postmenopausal with diabetes mellitus type 2. The patients will be randomized at baseline to denosumab 60 mg (n=20) or placebo (n=20), which will administrated at base-line and month 6.
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | Experimental | Drug: DenosumabDenosumab |
| Study group 2 | Placebo comparator | Drug: Saline (0.9% NaCl)Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal women (postmenopausal for at least two years)
- Age ≥ 40 years
- BMD T-score ≥ -2.0 (lumbar spine, total hip or femoral neck)
- At least 2 lumbar vertebrae that can be evaluated by dual-energy x-ray absorptiometry (DXA)
- Diabetes Mellitus type 2
Key exclusion criteria (11 listed)
- Treatment for osteoporosis at any time
- Other antidiabetic medication than metformin
- Low-energy vertebral fractures at any time
- Low-energy hip fracture at any time
- Ongoing treatment with systemic glucocorticoids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DenosumabDenosumab 60 mg | Drug | Study group 1 |
| Saline (0.9% NaCl)Also: PlaceboPlacebo | Drug | Study group 2 |
Primary outcome
Insulin sensitivity: HbA1c
Time frame: 12 months
Changes in Hb1Ac (mmol/mol) from baseline to month 12
Insulin sensitivity: HOMA-IR
Time frame: 12 months
Changes in HOMA-IR from baseline to month 12
Insulin sensitivity: fasting glucose
Time frame: 12 months
Changes in fasting glucose (mmol/l) from baseline to month 12
Insulin sensitivity: oral glucose tolerance test
Time frame: 12 months
Changes in oral glucose tolerance test (OGTT) (mmol/l) from baseline to month 12
Muscle mass
Time frame: 12 months
Changes in muscle mass (kg) from baseline to month 12.
Muscle strength
Time frame: 12 months
Changes in muscle strength (N) from baseline to month 12.
11 secondary outcomes
DPP-4
Time frame: 12 months
GLP-1
Time frame: 12 months
Bone turnover markers: CTX
Time frame: 12 months
Bone turnover markers: PINP
Time frame: 12 months
Bone Mineral Density
Time frame: 12 months
Advanced glycation end products (AGEs)
Time frame: 12 months
Muscle strength
Time frame: Month 1 and 3
Insulin sensitivity: Hb1Ac month 1 and 3
Time frame: Month 1 and 3
Insulin sensitivity: HOMA-IR month 1 and 3
Time frame: Month 1 and 3
insulin sensitivity: fasting glucose month 1 and 3
Time frame: Month 1 and 3
Insulin sensitivity: OGTT month 1 and 3
Time frame: Month 1 and 3
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 15 Dec 2025.
- Background: PubMed 31433518Anastasilakis AD, Papapoulos SE, Polyzos SA, Appelman-Dijkstra NM, Makras P. Zoledronate for the Prevention of Bone Loss in Women Discontinuing Denosumab Treatment. A Prospective 2-Year Clinical Trial. J Bone Miner Res. 2019 Dec;34(12):2220-2228. doi: 10.1002/jbmr.3853. Epub 2019 Oct 14.
- Background: PubMed 18539106Miller PD, Bolognese MA, Lewiecki EM, McClung MR, Ding B, Austin M, Liu Y, San Martin J. Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial. Bone. 2008 Aug;43(2):222-229. doi: 10.1016/j.bone.2008.04.007. Epub 2008 Apr 26.
- Background: PubMed 35751664Rupp T, von Vopelius E, Strahl A, Oheim R, Barvencik F, Amling M, Rolvien T. Beneficial effects of denosumab on muscle performance in patients with low BMD: a retrospective, propensity score-matched study. Osteoporos Int. 2022 Oct;33(10):2177-2184. doi: 10.1007/s00198-022-06470-3. Epub 2022 Jun 25.
- Background: PubMed 31483858Phu S, Bani Hassan E, Vogrin S, Kirk B, Duque G. Effect of Denosumab on Falls, Muscle Strength, and Function in Community-Dwelling Older Adults. J Am Geriatr Soc. 2019 Dec;67(12):2660-2661. doi: 10.1111/jgs.16165. Epub 2019 Sep 4. No abstract available.
- Background: PubMed 34008069Miedany YE, Gaafary ME, Toth M, Hegazi MO, Aroussy NE, Hassan W, Almedany S, Nasr A, Bahlas S, Galal S; Egyptian Academy of Bone Health, Metabolic Bone Diseases. Is there a potential dual effect of denosumab for treatment of osteoporosis and sarcopenia? Clin Rheumatol. 2021 Oct;40(10):4225-4232. doi: 10.1007/s10067-021-05757-w. Epub 2021 May 19.
- Background: PubMed 33204260Rossini A, Frigerio S, Dozio E, Trevisan R, Perseghin G, Corbetta S. Effect of Denosumab on Glucose Homeostasis in Postmenopausal Women with Breast Cancer Treated with Aromatase Inhibitors: A Pilot Study. Int J Endocrinol. 2020 Nov 6;2020:1809150. doi: 10.1155/2020/1809150. eCollection 2020.
- Background: PubMed 26498169Lasco A, Morabito N, Basile G, Atteritano M, Gaudio A, Giorgianni GM, Morini E, Faraci B, Bellone F, Catalano A. Denosumab Inhibition of RANKL and Insulin Resistance in Postmenopausal Women with Osteoporosis. Calcif Tissue Int. 2016 Feb;98(2):123-8. doi: 10.1007/s00223-015-0075-5. Epub 2015 Oct 24.
- Background: PubMed 25873952Passeri E, Benedini S, Costa E, Corbetta S. A Single 60 mg Dose of Denosumab Might Improve Hepatic Insulin Sensitivity in Postmenopausal Nondiabetic Severe Osteoporotic Women. Int J Endocrinol. 2015;2015:352858. doi: 10.1155/2015/352858. Epub 2015 Mar 19.
- Background: PubMed 29430796Napoli N, Pannacciulli N, Vittinghoff E, Crittenden D, Yun J, Wang A, Wagman R, Schwartz AV. Effect of denosumab on fasting glucose in women with diabetes or prediabetes from the FREEDOM trial. Diabetes Metab Res Rev. 2018 May;34(4):e2991. doi: 10.1002/dmrr.2991. Epub 2018 Apr 16.
- Background: PubMed 31764838Abe I, Ochi K, Takashi Y, Yamao Y, Ohishi H, Fujii H, Minezaki M, Sugimoto K, Kudo T, Abe M, Ohnishi Y, Mukoubara S, Kobayashi K. Effect of denosumab, a human monoclonal antibody of receptor activator of nuclear factor kappa-B ligand (RANKL), upon glycemic and metabolic parameters: Effect of denosumab on glycemic parameters. Medicine (Baltimore). 2019 Nov;98(47):e18067. doi: 10.1097/MD.0000000000018067.
- Background: PubMed 31120440Bonnet N, Bourgoin L, Biver E, Douni E, Ferrari S. RANKL inhibition improves muscle strength and insulin sensitivity and restores bone mass. J Clin Invest. 2019 May 23;129(8):3214-3223. doi: 10.1172/JCI125915.
- Background: PubMed 31911667Weivoda MM, Chew CK, Monroe DG, Farr JN, Atkinson EJ, Geske JR, Eckhardt B, Thicke B, Ruan M, Tweed AJ, McCready LK, Rizza RA, Matveyenko A, Kassem M, Andersen TL, Vella A, Drake MT, Clarke BL, Oursler MJ, Khosla S. Identification of osteoclast-osteoblast coupling factors in humans reveals links between bone and energy metabolism. Nat Commun. 2020 Jan 7;11(1):87. doi: 10.1038/s41467-019-14003-6.
- Individual participant dataSharing planned: No. All results including inconclusive, positive, and negative results will be accessible to the public after the study has ended. As soon as possible and no later than one year after the trial has ended, the trial results will be submitted to the CTIS-portal.
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Osteosarcopenia, Sarcopenia
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TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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.
Bente Langdahl, MD, Professor, DMSc, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Denosumab and Saline (0.9% NaCl) in people with Osteoporosis, run by Aarhus University Hospital 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 6 inclusion and 11 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 15 Dec 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Anne Sophie Sølling, MD, PhD (+45 22 30 05 24, annesoel@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity: HbA1c (time frame: 12 months). The study lists 6 primary outcomes in all. 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 NCT07271771, which also lists 15 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 15 Dec 2025.