Osteoporosis in Postmenopausal WomenPhase 4ESCORTNCT05884372
Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT)
A Phase 4 study testing Eldecalcitol, Native Vitamin D and Denosumab in people with Osteoporosis in Postmenopausal Women, run by Xi'an Honghui Hospital at 1 site in China.
Trial summary
Primary objective: To compare the bone mineral density (BMD) change under the treatment of denosumab with eldecalcitol or native vitamin D in postmenopausal women with osteoporosis on bone mineral density. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis in Postmenopausal Women
- What is being tested?
- Eldecalcitol, Native Vitamin D and Denosumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2023to 16 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1.Postmenopausal patients with osteoporosis, measured by dual energy X-ray absorptiometry (DXA), the T value of lumbar spine, femoral neck or total hip BMD is ≤-2.5, or with low mineral density (-2.5 < T-score < -1.0) plus a fragility fracture of the proximal humerus or distal forearm, or a history of vertebral compression fracture.
- 2.Voluntarily participate in this study and sign the informed consent.
Who cannot join
- 1.Suffering from hyperthyroidism, Cushing's syndrome, hypogonadism, poorly controlled diabetes mellitus (glycated hemoglobin [HbA1c>9.0%]), or other diseases that may lead to secondary osteoporosis.
- 2.Patients who have received denosumab therapy before screening: received oral bisphosphonate treatment more than 3 years or received bisphosphonate treatment within 6 months before screening, or received treatment with glucocorticoids, vitamin K, active vitamin D compounds, selective estrogen receptor modulators, calcitonin, hormone replacement therapy, or teriparatide within the 8 weeks prior to study enrollment..
- 3.Patients who at screening have urinary tract stones detected on B-mode ultrasonography or who have a prior history of urolithiasis.
- 4.Corrected serum calcium value at screening exceeds 2.6mmol/L (10.4mg/dL) or serum calcium value is lower than 2.12mmol/L(8 mg/dL) or hypercalciuria (> 0.4 mg/dL GF), or chronic kidney disease (eGFR < 30 mL/min/1.73 m2).
- 5.Patients with a history of malignant tumors.
- 6.Patients judged by investigators to be unsuitable as subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Primary objective:
To compare the bone mineral density (BMD) change under the treatment of denosumab with eldecalcitol or native vitamin D in postmenopausal women with osteoporosis on bone mineral density.
Secondary objective:
To compare the efficacy of denosumab with eldecalcitol or native vitamin D treatment in postmenopausal women with osteoporosis on bone turnover markers, serum PTH, serum calcium, serum phosphorus, muscle mass, muscle strength, body balance ability, and quality of life.
- Conditions
- Osteoporosis in Postmenopausal Women
- Being tested
- Eldecalcitol, Native Vitamin D, Denosumab, Calcium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EldecalcitolDrug
the same as arm descriptions.
Native Vitamin DDrug
the same as arm descriptions.
DenosumabDrug
the same as arm descriptions.
CalciumDrug
the same as arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Denosumab+Eldecalcitol | Experimental | Denosumab (subcutaneous injection 60mg/6 months) combined with ELD (oral 0.75μg/day) for 12 months. Receives: Drug: Eldecalcitol; Drug: Denosumab |
| Denosumab+Native Vitamin D+Calcium | Active comparator | Denosumab (subcutaneous injection 60mg/6 months) combined with native vitamin D (oral 800IU/day) and Calcium (oral 600mg/day) for 12 months. Receives: Drug: Native Vitamin D; Drug: Denosumab; Drug: Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percent change from baseline at month 12 in BMD at the lumbar spine L1-4.
the percent change from baseline at month 12 in BMD at the lumbar spine L1-4.
Measured: 12 months
Secondary outcomes (5)
the percent change from baseline at month 6 in BMD at the lumbar spine L1-4.
the percent change from baseline at month 6 in BMD at the lumbar spine L1-4.
Measured: 6 months
the percent change from baseline at each visit in BMD at the femoral neck and total hip.
the percent change from baseline at each visit in BMD at the femoral neck and total hip.
Measured: 12 months
the percent change from baseline at each visit in serum CTX,P1NP,PTH.
the percent change from baseline at each visit in serum CTX,P1NP,PTH.
Measured: 12 months
the score change from baseline at month 6 and month 12 in quality of life by 16-item Assessment of Health-Related Quality of Life in Osteoporosis,(ECOS-16).
the score change from baseline at month 6 and month 12 in quality of life by 16-item Assessment of Health-Related Quality of Life in Osteoporosis,(ECOS-16). The scale ranges from 16 to 80, with higher scores meaning higher risk.
Measured: 12 months
Incidence rate of new vertebral fracture and new non-vertebral fracture in 1 year.
Incidence rate of new vertebral fracture and new non-vertebral fracture in 1 year.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start24 Aug 2023
- Primary completion16 Jul 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis in Postmenopausal WomenStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xi'an Honghui Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chugai Pharma China Co., Ltd.
- Responsible party
- Principal investigator, Yuhong Zeng, Xi'an Honghui Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884372
- Sponsor's protocol ID
- ELD-IIS00X
- Acronym
- ESCORT
- Status last verified
- Nov 2025
- First submitted
- 7 May 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng Y, Tang Q, Yang J, Li Q, Yang L, Zhang B, Yang M, Che M, Peng Y. Comparison of Efficacy and Safety of Denosumab with Eldecalcitol or Native Vitamin D in Postmenopausal Chinese Women with Osteoporosis (ESCORT): A Randomized Controlled Trial. J Clin Med. 2026 Jul 16;15(14):5570. doi: 10.3390/jcm15145570.
PubMed 42513484
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT)
- ClinicalTrials.gov ID
- NCT05884372
- Acronym / sponsor ID
- ESCORT / ELD-IIS00X
- Conditions
- Osteoporosis in Postmenopausal Women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Xi'an Honghui HospitalUniversity, hospital or other
- Collaborators
- Chugai Pharma China Co., Ltd.
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 1 Jun 2023 (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.
Primary objective:
To compare the bone mineral density (BMD) change under the treatment of denosumab with eldecalcitol or native vitamin D in postmenopausal women with osteoporosis on bone mineral density.
Secondary objective:
To compare the efficacy of denosumab with eldecalcitol or native vitamin D treatment in postmenopausal women with osteoporosis on bone turnover markers, serum PTH, serum calcium, serum phosphorus, muscle mass, muscle strength, body balance ability, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab+Eldecalcitol | Experimental | Drug: Eldecalcitol, Drug: DenosumabDenosumab (subcutaneous injection 60mg/6 months) combined with ELD (oral 0.75μg/day) for 12 months. |
| Denosumab+Native Vitamin D+Calcium | Active comparator | Drug: Native Vitamin D, Drug: Denosumab, Drug: CalciumDenosumab (subcutaneous injection 60mg/6 months) combined with native vitamin D (oral 800IU/day) and Calcium (oral 600mg/day) for 12 months. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 1.Postmenopausal patients with osteoporosis, measured by dual energy X-ray absorptiometry (DXA), the T value of lumbar spine, femoral neck or total hip BMD is ≤-2.5, or with low mineral density (-2.5 < T-score < -1.0) plus a fragility fracture of the proximal humerus or distal forearm, or a history of vertebral compression fracture.
- 2.Voluntarily participate in this study and sign the informed consent.
Key exclusion criteria (6 listed)
- 1.Suffering from hyperthyroidism, Cushing's syndrome, hypogonadism, poorly controlled diabetes mellitus (glycated hemoglobin [HbA1c>9.0%]), or other diseases that may lead to secondary osteoporosis.
- 2.Patients who have received denosumab therapy before screening: received oral bisphosphonate treatment more than 3 years or received bisphosphonate treatment within 6 months before screening, or received treatment with glucocorticoids, vitamin K, active vitamin D compounds, selective estrogen receptor modulators, calcitonin, hormone replacement therapy, or teriparatide within the 8 weeks prior to study enrollment..
- 3.Patients who at screening have urinary tract stones detected on B-mode ultrasonography or who have a prior history of urolithiasis.
- 4.Corrected serum calcium value at screening exceeds 2.6mmol/L (10.4mg/dL) or serum calcium value is lower than 2.12mmol/L(8 mg/dL) or hypercalciuria (> 0.4 mg/dL GF), or chronic kidney disease (eGFR < 30 mL/min/1.73 m2).
- 5.Patients with a history of malignant tumors.
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 |
|---|---|---|
| Eldecalcitolthe same as arm descriptions. | Drug | Denosumab+Eldecalcitol |
| Native Vitamin Dthe same as arm descriptions. | Drug | Denosumab+Native Vitamin D+Calcium |
| Denosumabthe same as arm descriptions. | Drug | Denosumab+Eldecalcitol, Denosumab+Native Vitamin D+Calcium |
| Calciumthe same as arm descriptions. | Drug | Denosumab+Native Vitamin D+Calcium |
Primary outcome
the percent change from baseline at month 12 in BMD at the lumbar spine L1-4.
Time frame: 12 months
the percent change from baseline at month 12 in BMD at the lumbar spine L1-4.
5 secondary outcomes
the percent change from baseline at month 6 in BMD at the lumbar spine L1-4.
Time frame: 6 months
the percent change from baseline at each visit in BMD at the femoral neck and total hip.
Time frame: 12 months
the percent change from baseline at each visit in serum CTX,P1NP,PTH.
Time frame: 12 months
the score change from baseline at month 6 and month 12 in quality of life by 16-item Assessment of Health-Related Quality of Life in Osteoporosis,(ECOS-16).
Time frame: 12 months
Incidence rate of new vertebral fracture and new non-vertebral fracture in 1 year.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 42513484Zeng Y, Tang Q, Yang J, Li Q, Yang L, Zhang B, Yang M, Che M, Peng Y. Comparison of Efficacy and Safety of Denosumab with Eldecalcitol or Native Vitamin D in Postmenopausal Chinese Women with Osteoporosis (ESCORT): A Randomized Controlled Trial. J Clin Med. 2026 Jul 16;15(14):5570. doi: 10.3390/jcm15145570.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Eldecalcitol, Native Vitamin D and Denosumab in people with Osteoporosis in Postmenopausal Women, run by Xi'an Honghui Hospital at 1 site in China.
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 6 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: finished, as of the sponsor's last update on 24 Nov 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 China. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percent change from baseline at month 12 in BMD at the lumbar spine L1-4. (time frame: 12 months). 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 NCT05884372, which also lists 1 linked publication.
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 24 Nov 2025.