Low Bone Mineral DensityPhase 4EFFECTNCT05902078
Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
A Phase 4 study testing Eldecalcitol capsules and Calcitriol capsules in people with Low Bone Mineral Density and Postmenopausal Osteoporosis, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 21 sites in China.
Trial summary
To investigate the efficacy and safety of eldecalcitol in postmenopausal women with low bone mineral density (BMD) or mild osteoporosis through a randomized, open-label, parallel controlled trial with calcitriol as the control. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Low Bone Mineral Density, Postmenopausal Osteoporosis
- What is being tested?
- Eldecalcitol capsules and Calcitriol capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 21 sitesChina
- Study dates
- 27 Sep 2023to Dec 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women (based on medical history) aged 50 or older and menopause time more than 2 years. If there is uncertainty regarding menopausal status, women 60 years of age and older will be considered postmenopausal.
- BMD (determined by DXA) of lumbar L1-4 or total hip or femoral neck met one of the following conditions at screening:
- 1) low BMD: -2.5<T< -1.0, without vertebral and fragility fracture history 2) mild osteoporosis: T≤-2.5, without vertebral and fragility fracture history 3. Ambulatory outpatients 4. Written informed consent
Who cannot join
- Severe vitamin D deficiency at screening (defined as serum 25OHD<10 ng/ml);Vitamin D repletion will be permitted and dosage will be at the discretion of investigators and subjects may be re-screened
- Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadal insufficiency, osteogenesis impotence, rheumatoid arthritis, poorly controlled diabetes mellitus (HbA1c>9%), or other conditions that can cause secondary osteoporosis, or treatment with glucocorticoids in the 2 months prior to study entry
- Had injected bisphosphonate once or more within 3 years before entering the study; or had received oral bisphosphonate oral for 6 months or more in the 3 years prior to study entry; or had received parathyroid hormone once or more in the 3 years before entering the study; or received 2 weeks or more of calcitonin or vitamin K or active vitamin D or selective estrogen receptor modulator or hormone replacement therapy or traditional Chinese medicine for bone pine within 2 months prior to study entry; or received subcutaneous anti-RANKL antibody at any time prior to study entry
- Urolithiasis at screening
- Hypercalcemia (serum calcium >10.4 mg/dL), or hypercalciuria (urine calcium>400 mg/gCr), or hyperuricemia (above 420 μmol/L in men and 360 μmol/L in women)
- Severe liver disease such as cirrhosis or serious heart disease such as severe heart failure
Show all 9Show fewer
- Active malignant tumors or a history of malignant tumors within 5 years before informed consent obtained
- History of allergy to vitamin D
- Any condition which in the opinion of the investigator unfit for the study
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites, 1 recruiting
- Completed
The Second Xiangya Hospital of Central South University
Changsha
- Recruiting
The Fourth Affiliated Hospital of Harbin Medical University
Ha’erbin
Zhifeng Cheng
Zhifeng Cheng
- Completed
Zhejiang Provincial People's Hospital
Hangzhou
- Completed
Huai 'an First People's Hospital
Huai'an
- Completed
Liaocheng People's Hospital
Liaocheng
- Completed
Jiangxi Provincial People's Hospital
Nanchang
- Completed
Jiangsu Geriatric Hospital
Nanjin
- Completed
The First Hospital of Ningbo
Ningbo
- Completed
The Sixth Hospital of Ningbo
Ningbo
- Completed
Pingxiang People's Hospital
Pingxiang
- Completed
Huadong Hospital Affiliated to Fudan University
Shanghai
- Completed
Shanghai First People's Hospital
Shanghai
- Completed
Shanghai Pudong New Area Punan Hospital
Shanghai
- Completed
Shanghai Sixth People's Hospital
Shanghai
- Completed
Zhongshan Hosiptal Affiliated to Fudan University
Shanghai
- Completed
The Second Affiliated Hospital of Soochow University
Suzhou
- Completed
The First Hospital of Shanxi Medical University
Taiyuan
- Completed
The Second Hospital of Shanxi Medical University
Taiyuan
- Completed
Tianjin Hospital
Tianjin
- Completed
Xi'an Honghui Hospital
Xi'an
- Completed
Xuzhou Central Hospital
Xuzhou
About this study
Official title: Comparison of the Efficacy and Safety With Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
To investigate the efficacy and safety of eldecalcitol in postmenopausal women with low bone mineral density (BMD) or mild osteoporosis through a randomized, open-label, parallel controlled trial with calcitriol as the control.
Read the detailed description
Postmenopausal women with low bone mineral density (BMD) or mild osteoporosis will be randomized in a 1:1 ratio to receive open-label oral 0.75μg eldecalcit daily or open-label oral 0.5μg calcitriol daily for 12 months.
- Being tested
- Eldecalcitol capsules, Calcitriol capsules
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eldecalcitol capsulesDrug
Also called Edirol
Oral eldecalcitol 0.75μg daily
Calcitriol capsulesDrug
Also called Haidewei
Oral calcitriol 0.5μg daily
| Study group | Role | What they receive |
|---|---|---|
| Eldecalcitol | Experimental | Participants receive oral eldecalcitol 0.75μg daily for 12 months Receives: Drug: Eldecalcitol capsules |
| Calcitriol | Active comparator | Participants receive oral calcitriol 0.5μg daily for 12 months Receives: Drug: Calcitriol capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Measured: Baseline to 12 months
Secondary outcomes (10)
Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Measured: Baseline to 6 months
Percent Change From Baseline at Month 6 in BMD of the Total Hip
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Measured: Baseline to 6 months
Percent Change From Baseline at Month 6 in BMD of the Femoral Neck
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Measured: Baseline to 6 months
Percent Change From Baseline at Month 12 in BMD of the Total Hip
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Measured: Baseline to 6 months
Percent Change From Baseline at Month 12 in BMD of the Femoral Neck
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
Measured: Baseline to 12 months
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Serum P1NP will be determined
Measured: Baseline and months 6 and 12
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Serum CTX will be determined
Measured: Baseline and months 6 and 12
Percent Change From Baseline in Parathyroid Hormone (PTH)
Serum PTH will be determined
Measured: Baseline and months 6 and 12
Percent Change From Baseline in 25-Hydroxyvitamin D [25(OH)D]
Serum 25(OH)D will be determined
Measured: Baseline and months 6 and 12
Incidence of new vertebral fracture
New vertebral fracture will be confirmed by the lateral X-ray of thoracic/lumbar vertebrae
Measured: Baseline and months 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start27 Sep 2023
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Bone Mineral DensityStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chugai Pharma China Co., Ltd.
- Responsible party
- Principal investigator, Zhenlin Zhang, MD, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Investigators
- Zhenlin Zhang, Principal investigator, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902078
- Sponsor's protocol ID
- 2023MDEDR0007
- Acronym
- EFFECT
- Status last verified
- May 2024
- First submitted
- 5 Jun 2023
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety With Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
- ClinicalTrials.gov ID
- NCT05902078
- Acronym / sponsor ID
- EFFECT / 2023MDEDR0007
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Collaborators
- Chugai Pharma China Co., Ltd.
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 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.
To investigate the efficacy and safety of eldecalcitol in postmenopausal women with low bone mineral density (BMD) or mild osteoporosis through a randomized, open-label, parallel controlled trial with calcitriol as the control.
Detailed description
Postmenopausal women with low bone mineral density (BMD) or mild osteoporosis will be randomized in a 1:1 ratio to receive open-label oral 0.75μg eldecalcit daily or open-label oral 0.5μg calcitriol daily for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eldecalcitol | Experimental | Drug: Eldecalcitol capsulesParticipants receive oral eldecalcitol 0.75μg daily for 12 months |
| Calcitriol | Active comparator | Drug: Calcitriol capsulesParticipants receive oral calcitriol 0.5μg daily for 12 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women (based on medical history) aged 50 or older and menopause time more than 2 years. If there is uncertainty regarding menopausal status, women 60 years of age and older will be considered postmenopausal.
- BMD (determined by DXA) of lumbar L1-4 or total hip or femoral neck met one of the following conditions at screening:
- 1) low BMD: -2.5<T< -1.0, without vertebral and fragility fracture history 2) mild osteoporosis: T≤-2.5, without vertebral and fragility fracture history 3. Ambulatory outpatients 4. Written informed consent
Key exclusion criteria (9 listed)
- Severe vitamin D deficiency at screening (defined as serum 25OHD<10 ng/ml);Vitamin D repletion will be permitted and dosage will be at the discretion of investigators and subjects may be re-screened
- Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadal insufficiency, osteogenesis impotence, rheumatoid arthritis, poorly controlled diabetes mellitus (HbA1c>9%), or other conditions that can cause secondary osteoporosis, or treatment with glucocorticoids in the 2 months prior to study entry
- Had injected bisphosphonate once or more within 3 years before entering the study; or had received oral bisphosphonate oral for 6 months or more in the 3 years prior to study entry; or had received parathyroid hormone once or more in the 3 years before entering the study; or received 2 weeks or more of calcitonin or vitamin K or active vitamin D or selective estrogen receptor modulator or hormone replacement therapy or traditional Chinese medicine for bone pine within 2 months prior to study entry; or received subcutaneous anti-RANKL antibody at any time prior to study entry
- Urolithiasis at screening
- Hypercalcemia (serum calcium >10.4 mg/dL), or hypercalciuria (urine calcium>400 mg/gCr), or hyperuricemia (above 420 μmol/L in men and 360 μmol/L in women)
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 |
|---|---|---|
| Eldecalcitol capsulesAlso: EdirolOral eldecalcitol 0.75μg daily | Drug | Eldecalcitol |
| Calcitriol capsulesAlso: HaideweiOral calcitriol 0.5μg daily | Drug | Calcitriol |
Primary outcome
Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine
Time frame: Baseline to 12 months
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader.
10 secondary outcomes
Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine
Time frame: Baseline to 6 months
Percent Change From Baseline at Month 6 in BMD of the Total Hip
Time frame: Baseline to 6 months
Percent Change From Baseline at Month 6 in BMD of the Femoral Neck
Time frame: Baseline to 6 months
Percent Change From Baseline at Month 12 in BMD of the Total Hip
Time frame: Baseline to 6 months
Percent Change From Baseline at Month 12 in BMD of the Femoral Neck
Time frame: Baseline to 12 months
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Time frame: Baseline and months 6 and 12
Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Time frame: Baseline and months 6 and 12
Percent Change From Baseline in Parathyroid Hormone (PTH)
Time frame: Baseline and months 6 and 12
Percent Change From Baseline in 25-Hydroxyvitamin D [25(OH)D]
Time frame: Baseline and months 6 and 12
Incidence of new vertebral fracture
Time frame: Baseline and months 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- 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.
Zhenlin Zhang principal investigator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
21 sites 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 capsules and Calcitriol capsules in people with Low Bone Mineral Density and Postmenopausal Osteoporosis, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 21 sites 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Shen ((+86)15800674978, shenli_0510@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.