Hypovitaminosis DNCT05372224
Effect of Vitamin D and Denosumab on Bone Remodelling in Women With Postmenopausal Osteoporosis
A study testing Cholecalciferol in people with Hypovitaminosis D and Osteoporosis, Postmenopausal, run by Hospital Regional 1o de Octubre at 1 site in Mexico.
Trial summary
Denosumab is a monoclonal antibody against RANKL ligand, which is used as an alternative treatment for osteoporosis in patients who have a poor response to first-line antiresorptive therapy. Read more about this study
- Who is it for?
- Ages 45 to 89 years, women only
- Conditions the study is for
- Hypovitaminosis D, Osteoporosis, Postmenopausal, Menopause
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteMexico
- Study dates
- 22 Jun 2020to 22 Jun 2021
- Phase
- Interventional
- 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 45 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of postmenopausal osteoporosis or osteopenia in treatment with denosumab 60mg every six months plus calcium carbonate 1.2g/day + vitamin D 800IU/day.
- Diagnosis of hypovitaminosis D, with serum cholecalciferol values <30ng/dL.
Who cannot join
- Incomplete clinical records or clinical records.
- Age over 90 years.
- Diagnosis of secondary (hereditary) osteoporosis.
- History of prolonged use of steroids.
- Lack of adherence to medical treatment.
- Diagnosis of cancer.
Show all 9Show fewer
- Diagnosis of depression.
- Diagnosis of Celiac disease or with the presence of alterations in intestinal absorption.
- Allergies to any of the medications administered.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Improves Osteoporosis in Postmenopausal Women With Denosumab Failure
Denosumab is a monoclonal antibody against RANKL ligand, which is used as an alternative treatment for osteoporosis in patients who have a poor response to first-line antiresorptive therapy. However, discontinuation of denosumab produces a rapid increase in bone turnover, bone loss and potentially increased risk of multiple vertebral fractures.
Read the detailed description
76 postmenopausal women from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE) were firstly considered, of which 23 presented elimination criteria and only 55 who had received denosumab therapy for an average of 2.5 years without a significant improvement in hip and lumbar spine T-scores were enrolled. First, a general medical evaluation was performed. Serum levels of vitamin D were analysed to find the prevalence of hypovitaminosis D. A bone mineral density test was done to calculate hip and lumbar spine T-scores. Then, vitamin D was administrated daily for one year at a dose of 4,000 IU and the studies were repeated after one year. Statistical analysis was performed using PAST 3.0 and GraphPad Prism 8.4.3. software. The arithmetic median (µ) and standard deviation (S.D.) were calculated using Excel-Word. Graphics were constructed with GraphPad Prism 8.4.3 and tables with Excel Word. Categorical variables were analysed with chi-squared or Fisher exact test depending on the number of participants in each cell. Normality was determined using the Shapiro-Wilk test. To compare two paired samples, the Wilcoxon signed-rank test was utilized. The assigned α value for this study was <0.05. In all cases, if a Montecarlo permutation was available, the exact p-value was taken instead of the raw p-value.
- Conditions
- Hypovitaminosis D, Osteoporosis, Postmenopausal, Menopause
- Being tested
- Cholecalciferol
- Keywords
- Vitamin D, Postmenopausal Osteoporosis, Denosumab, Hypovitaminosis D, Osteoporosis, Osteopenia
- Medical subject headings
- Vitamin D Deficiency, Osteoporosis, Postmenopausal, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Histofil®
4000 IU were administrated once a day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D 4000 IU | Experimental | 4000 IU of vitamin D were administrated once a day orally and calcium carbonate 1.2 g a day in a single dose. Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with hip T-score improvement at 12 months
It refers to the number of participants who improved their hip T-score at three months after treatment.
Measured: 12 months
Number of participants with lumbar spine T-score improvement at 12 months
It refers to the number of participants who improved their lumbar spine T-score at three months after treatment.
Measured: 12 months
Number of participants with osteoporosis of the hip at 12 months
It refers to the number of participants that present a hip T-score above -2.5 three months after treatment.
Measured: 12 months
Number of participants with osteoporosis of the lumbar spine at 12 months
It refers to the number of participants that present a lumbar spine T-score greater than -2.5 three months after treatment.
Measured: 12 months
Number of participants with osteopenia on the hip at 12 months
It refers to the number of participants that present a hip T-score from -1 to -2.4 three months after treatment.
Measured: 12 months
Number of participants with osteopenia of the lumbar spine at 12 months
It refers to the number of participants that present a lumbar spine T-score from -1 to -2.4 three months after treatment.
Measured: 12 months
Number of participants with normal hip T-score at 12 months
It refers to the number of participants that present a hip T-score below -1 three months after treatment.
Measured: 12 months
Number of participants with normal lumbar spine T-score at 12 months
It refers to the number of participants that present a lumbar spine T-score below -1 three months after treatment.
Measured: 12 months
Number of participants with improvement in serum levels of vitamin D at 12 months
Improvement in serum levels of 25-hydroxy vitamin D [25(OH)D] was considered when serum vitamin D levels increased concerning baseline levels.
Measured: 12 months
Number of participants with clinical remission of hypovitaminosis D at 12 months
Remission of hypovitaminosis D was considered when serum levels of 25-hydroxy vitamin D [25(OH)D] were above 29 pg/ml.
Measured: 12 months
Secondary outcomes (3)
Number of participants with vitamin D sufficiency at 12 months
It refers to the number of participants who reached serum levels of vitamin D above 29 pg/ml after three months of treatment.
Measured: 12 months
Number of participants with vitamin D insufficiency at 12 months
It refers to the number of participants who reached serum levels of vitamin D of 21 to 29 pg/ml after three months of treatment.
Measured: 12 months
Number of participants with vitamin D deficiency at 12 months
It refers to the number of participants who reached serum levels of vitamin D less than 20 pg/ml after three months of treatment.
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 posted12 May 2022
- Study start22 Jun 2020
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hypovitaminosis DStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 76 participants were considered from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE), of which 23 presented elimination criteria, and 55 were included in the study.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Regional 1o de Octubre
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, National Polytechnic Institute, Mexico
- Responsible party
- Sponsor
- Investigators
- María B Brito-Gavilanes, M.D., Principal investigator, Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1 ISSSTEPatricia Loranca-Moreno, M.D., M.Sc., Principal investigator, Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.Juan M Ocampo-Godínez, M.D., P.hD, Principal investigator, Laboratory of Tissue Engineering, UNAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372224
- Sponsor's protocol ID
- 032.2020
- Status last verified
- Feb 2023
- First submitted
- 9 May 2022
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tsourdi E, Langdahl B, Cohen-Solal M, Aubry-Rozier B, Eriksen EF, Guanabens N, Obermayer-Pietsch B, Ralston SH, Eastell R, Zillikens MC. Discontinuation of Denosumab therapy for osteoporosis: A systematic review and position statement by ECTS. Bone. 2017 Dec;105:11-17. doi: 10.1016/j.bone.2017.08.003. Epub 2017 Aug 5.
PubMed 28789921McClung MR, Wagman RB, Miller PD, Wang A, Lewiecki EM. Observations following discontinuation of long-term denosumab therapy. Osteoporos Int. 2017 May;28(5):1723-1732. doi: 10.1007/s00198-017-3919-1. Epub 2017 Jan 31.
PubMed 28144701Kanis JA, Cooper C, Rizzoli R, Reginster JY; Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis (ESCEO) and the Committees of Scientific Advisors and National Societies of the International Osteoporosis Foundation (IOF). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2019 Jan;30(1):3-44. doi: 10.1007/s00198-018-4704-5. Epub 2018 Oct 15.
PubMed 30324412Miyoshi A, Kameda H, Nagai S, Nakamura A, Miya A, Takase T, Atsumi T, Miyoshi H. Beneficial effects of switching to denosumab from bisphosphonates or selective estrogen receptor modulators in postmenopausal women with type 2 diabetes and osteopenia/osteoporosis. J Diabetes Investig. 2021 Jul;12(7):1293-1300. doi: 10.1111/jdi.13458. Epub 2020 Dec 13.
PubMed 33141482Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.
PubMed 28892457Cummings 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 19671655Takeuchi T, Tanaka Y, Soen S, Yamanaka H, Yoneda T, Tanaka S, Nitta T, Okubo N, Genant HK, van der Heijde D. Effects of the anti-RANKL antibody denosumab on joint structural damage in patients with rheumatoid arthritis treated with conventional synthetic disease-modifying antirheumatic drugs (DESIRABLE study): a randomised, double-blind, placebo-controlled phase 3 trial. Ann Rheum Dis. 2019 Jul;78(7):899-907. doi: 10.1136/annrheumdis-2018-214827. Epub 2019 Apr 29.
PubMed 31036625
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Improves Osteoporosis in Postmenopausal Women With Denosumab Failure
- ClinicalTrials.gov ID
- NCT05372224
- Acronym / sponsor ID
- 032.2020
- Conditions
- Hypovitaminosis D, Osteoporosis, Postmenopausal, Menopause
- Keywords
- Vitamin D, Postmenopausal Osteoporosis, Denosumab, Hypovitaminosis D, Osteoporosis, Osteopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hospital Regional 1o de OctubreUniversity, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, National Polytechnic Institute, Mexico
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 12 May 2022 (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.
Denosumab is a monoclonal antibody against RANKL ligand, which is used as an alternative treatment for osteoporosis in patients who have a poor response to first-line antiresorptive therapy. However, discontinuation of denosumab produces a rapid increase in bone turnover, bone loss and potentially increased risk of multiple vertebral fractures.
Detailed description
76 postmenopausal women from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE) were firstly considered, of which 23 presented elimination criteria and only 55 who had received denosumab therapy for an average of 2.5 years without a significant improvement in hip and lumbar spine T-scores were enrolled. First, a general medical evaluation was performed. Serum levels of vitamin D were analysed to find the prevalence of hypovitaminosis D. A bone mineral density test was done to calculate hip and lumbar spine T-scores. Then, vitamin D was administrated daily for one year at a dose of 4,000 IU and the studies were repeated after one year. Statistical analysis was performed using PAST 3.0 and GraphPad Prism 8.4.3. software. The arithmetic median (µ) and standard deviation (S.D.) were calculated using Excel-Word. Graphics were constructed with GraphPad Prism 8.4.3 and tables with Excel Word. Categorical variables were analysed with chi-squared or Fisher exact test depending on the number of participants in each cell. Normality was determined using the Shapiro-Wilk test. To compare two paired samples, the Wilcoxon signed-rank test was utilized. The assigned α value for this study was <0.05. In all cases, if a Montecarlo permutation was available, the exact p-value was taken instead of the raw p-value.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 76 participants were considered from the climacteric clinic of the regional hospital "1o de Octubre" of the Institute of Security and Social Services for State Workers (ISSSTE), of which 23 presented elimination criteria, and 55 were included in the study.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D 4000 IU | Experimental | Drug: Cholecalciferol4000 IU of vitamin D were administrated once a day orally and calcium carbonate 1.2 g a day in a single dose. |
Who may qualify
- Ages
- 45 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of postmenopausal osteoporosis or osteopenia in treatment with denosumab 60mg every six months plus calcium carbonate 1.2g/day + vitamin D 800IU/day.
- Diagnosis of hypovitaminosis D, with serum cholecalciferol values <30ng/dL.
Key exclusion criteria (9 listed)
- Incomplete clinical records or clinical records.
- Age over 90 years.
- Diagnosis of secondary (hereditary) osteoporosis.
- History of prolonged use of steroids.
- Lack of adherence to medical treatment.
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 |
|---|---|---|
| CholecalciferolAlso: Histofil®4000 IU were administrated once a day for 3 months. | Drug | Vitamin D 4000 IU |
Primary outcome
Number of participants with hip T-score improvement at 12 months
Time frame: 12 months
It refers to the number of participants who improved their hip T-score at three months after treatment.
Number of participants with lumbar spine T-score improvement at 12 months
Time frame: 12 months
It refers to the number of participants who improved their lumbar spine T-score at three months after treatment.
Number of participants with osteoporosis of the hip at 12 months
Time frame: 12 months
It refers to the number of participants that present a hip T-score above -2.5 three months after treatment.
Number of participants with osteoporosis of the lumbar spine at 12 months
Time frame: 12 months
It refers to the number of participants that present a lumbar spine T-score greater than -2.5 three months after treatment.
Number of participants with osteopenia on the hip at 12 months
Time frame: 12 months
It refers to the number of participants that present a hip T-score from -1 to -2.4 three months after treatment.
Number of participants with osteopenia of the lumbar spine at 12 months
Time frame: 12 months
It refers to the number of participants that present a lumbar spine T-score from -1 to -2.4 three months after treatment.
Number of participants with normal hip T-score at 12 months
Time frame: 12 months
It refers to the number of participants that present a hip T-score below -1 three months after treatment.
Number of participants with normal lumbar spine T-score at 12 months
Time frame: 12 months
It refers to the number of participants that present a lumbar spine T-score below -1 three months after treatment.
Number of participants with improvement in serum levels of vitamin D at 12 months
Time frame: 12 months
Improvement in serum levels of 25-hydroxy vitamin D [25(OH)D] was considered when serum vitamin D levels increased concerning baseline levels.
Number of participants with clinical remission of hypovitaminosis D at 12 months
Time frame: 12 months
Remission of hypovitaminosis D was considered when serum levels of 25-hydroxy vitamin D [25(OH)D] were above 29 pg/ml.
3 secondary outcomes
Number of participants with vitamin D sufficiency at 12 months
Time frame: 12 months
Number of participants with vitamin D insufficiency at 12 months
Time frame: 12 months
Number of participants with vitamin D deficiency at 12 months
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 17 Feb 2023.
- Background: PubMed 28789921Tsourdi E, Langdahl B, Cohen-Solal M, Aubry-Rozier B, Eriksen EF, Guanabens N, Obermayer-Pietsch B, Ralston SH, Eastell R, Zillikens MC. Discontinuation of Denosumab therapy for osteoporosis: A systematic review and position statement by ECTS. Bone. 2017 Dec;105:11-17. doi: 10.1016/j.bone.2017.08.003. Epub 2017 Aug 5.
- Background: PubMed 28144701McClung MR, Wagman RB, Miller PD, Wang A, Lewiecki EM. Observations following discontinuation of long-term denosumab therapy. Osteoporos Int. 2017 May;28(5):1723-1732. doi: 10.1007/s00198-017-3919-1. Epub 2017 Jan 31.
- Background: PubMed 30324412Kanis JA, Cooper C, Rizzoli R, Reginster JY; Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis (ESCEO) and the Committees of Scientific Advisors and National Societies of the International Osteoporosis Foundation (IOF). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2019 Jan;30(1):3-44. doi: 10.1007/s00198-018-4704-5. Epub 2018 Oct 15.
- Background: PubMed 33141482Miyoshi A, Kameda H, Nagai S, Nakamura A, Miya A, Takase T, Atsumi T, Miyoshi H. Beneficial effects of switching to denosumab from bisphosphonates or selective estrogen receptor modulators in postmenopausal women with type 2 diabetes and osteopenia/osteoporosis. J Diabetes Investig. 2021 Jul;12(7):1293-1300. doi: 10.1111/jdi.13458. Epub 2020 Dec 13.
- Background: PubMed 28892457Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.
- Background: PubMed 19671655Cummings 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.
- Background: PubMed 31036625Takeuchi T, Tanaka Y, Soen S, Yamanaka H, Yoneda T, Tanaka S, Nitta T, Okubo N, Genant HK, van der Heijde D. Effects of the anti-RANKL antibody denosumab on joint structural damage in patients with rheumatoid arthritis treated with conventional synthetic disease-modifying antirheumatic drugs (DESIRABLE study): a randomised, double-blind, placebo-controlled phase 3 trial. Ann Rheum Dis. 2019 Jul;78(7):899-907. doi: 10.1136/annrheumdis-2018-214827. Epub 2019 Apr 29.
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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.
María B Brito-Gavilanes, M.D. principal investigator
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1 ISSSTE
Patricia Loranca-Moreno, M.D., M.Sc. principal investigator
Peri-postmenopause and bone metabolism clinic. Regional Hospital October 1st ISSSTE.
Juan M Ocampo-Godínez, M.D., P.hD principal investigator
Laboratory of Tissue Engineering, UNAM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Hypovitaminosis D and Osteoporosis, Postmenopausal, run by Hospital Regional 1o de Octubre at 1 site in Mexico.
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 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: finished, as of the sponsor's last update on 17 Feb 2023. 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 Mexico. 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?
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?
Number of participants with hip T-score improvement at 12 months (time frame: 12 months). The study lists 10 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 NCT05372224, which also lists 7 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 Feb 2023.