OsteopeniaPhase 2NCT01406548
Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density
A Phase 2 study testing BPS804 20mg/Kg in people with Osteopenia and Osteoporosis, run by Ultragenyx Pharmaceutical Inc at 5 sites in United States.
Trial summary
This study is designed to provide information on the safety, tolerability, pharmacokinetics (PK) and bone biomarker response following multiple BPS804 administration in multiple dosing regimens. Read more about this study
- Who is it for?
- Ages 45 to 85 years, women only
- Conditions the study is for
- Osteopenia, Osteoporosis
- What is being tested?
- BPS804 20mg/Kg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2011to Oct 2013
- Phase
- Phase 2
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women (natural or surgically induced menopause)
- Low bone mineral density (BMD), as defined by a T score or equivalent BMD absolute value (g/cm2) for lumbar spine of between -2.0 and -3.5, inclusive
- Body mass index (BMI) must be within the range of 18 to 35kg/m2. Subjects must weigh between 45 and 120kg inclusive to participate.
- 25-(OH) vitamin D serum level of ≥ 15ng/ml
- Serum calcium within normal limits
Who cannot join
- Subjects with suspected neural foraminal stenosis (e.g., cervical, spinal, lumbar), or history of Bell's palsy, cranial nerve disorders, temporomandibular joint and muscle disorders.
- Subjects who have an increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained and clinically significant elevations of alkaline phosphatase and/or subjects who have received radiation therapy involving the skeleton.
- Subjects with any known bone diseases other than postmenopausal osteoporosis.
- Subjects with a history of an osteoporotic fracture (e.g., vertebral fracture, fragility fracture of the wrist, radius, humerus, hip, or pelvis).
- Subjects who are regularly using or have regularly used agents affecting bone metabolism:
- Calcitonin, estrogen, SERMs (raloxifene, Tamoxifen, etc.), Tibolone progestin, or androgens within the last three (3) months prior to screening.
Show all 11Show fewer
- Any oral bisphosphonate, lithium chloride, fluoride or systemic glucocorticosteroids (p.o. or i.v.) where the total dose exceeds 750 mg of prednisone or equivalent within the last year prior to screening.
- Any previous use of denusomab (ProliaTM), parathyroid hormone (ForteoTM), and/or PTH analogs, strontium ranelate, or parenteral formulations of bisphosphonates.
- Current disease(s) known to influence calcium metabolism including hyperparathyroidism, hypoparathyroidism, hypocalcemia or hypercalcemia.
- Any disease, abnormality or deformation of the spine (e.g., scoliosis, ankylosing spondylitis, osteophytes) or hip (e.g., joint prosthesis) which would preclude the proper acquisition of a lumbar spine DXA (L1-L4) or femur DXA, respectively.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Novartis Investigative Site
Anaheim, California, 92801-2811
Novartis Investigative Site
Berlin, New Jersey, 08009
Novartis Investigative Site
Duncansville, Pennsylvania, 16635
Novartis Investigative Site
Miami, Florida, 33126
Novartis Investigative Site
Miami, Florida, 33175
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Assess the Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density
This study is designed to provide information on the safety, tolerability, pharmacokinetics (PK) and bone biomarker response following multiple BPS804 administration in multiple dosing regimens. This information will permit a comparison of the possible risks and benefits of different dosing regimens of the study drug to enable optimal doses and dose intervals to be tested in subsequent studies.
Read the detailed description
This study was conducted and previously posted by Novartis. The record was transferred to Ultragenyx in February 2021.
- Conditions
- Osteopenia, Osteoporosis
- Being tested
- BPS804 20mg/Kg, Placebo to 20mg/Kg BPS804
- Keywords
- Osteopenia, osteoporosis, low bone mineral density
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPS804 20mg/KgDrug
Placebo to 20mg/Kg BPS804Drug
| Study group | Role | What they receive |
|---|---|---|
| BPS804 dosing frequency 1 | Experimental | Subjects dosed 20mg/Kg BPS804 monthly Receives: Drug: BPS804 20mg/Kg |
| placebo dosing frequency 1 | Placebo comparator | Subjects dosed with matching placebo to 20mg/Kg BPS804 monthly Receives: Drug: Placebo to 20mg/Kg BPS804 |
| BPS804 dosing frequency 2 | Experimental | Subjects dosed with 20mg/Kg BPS804 quarterly Receives: Drug: BPS804 20mg/Kg |
| placebo dosing frequency 2 | Placebo comparator | Subjects dosed with matching placebo to 20mg/Kg BPS804 every 3 months Receives: Drug: Placebo to 20mg/Kg BPS804 |
| BPS804 dosing frequency 3 | Experimental | Subjects dosed with 20mg/Kg BPS804 weekly Receives: Drug: BPS804 20mg/Kg |
| Placebo dosing frequency 3 | Placebo comparator | Subjects dosed with matching placebo to 20mg/Kg BPS804 weekly Receives: Drug: Placebo to 20mg/Kg BPS804 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to month 9 in bone mineral density at the lumbar spine for the individual BPS804 groups and pooled placebo arms.
Measured: 9 months
The number (percent) of subjects experiencing adverse events or serious adverse events
Measured: 9 months
Secondary outcomes (5)
Change from baseline during 9 months of serological bone biomarkers for the individual BPS804 groups and pooled placebo arms.
Measured: 9 months
Characterization of the PK profile of BPS804: area under the plasma concentration-time curve (AUC)
Measured: 260 days
Characterization of the PK profile of BPS804: time to reach the maximum Characterization of the PK profile of BPS804: maximum plasma concentration (Cmax)
Measured: 260 days
Characterization of the PK profile: time to reach the maximum concentration (Tmax)
Measured: 260 days
Characterization of the PK profile of BPS804: half-life (T1/2)
Measured: 260 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by Ultragenyx Pharmaceutical IncThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ultragenyx Pharmaceutical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mereo BioPharma, Novartis
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Ultragenyx Pharmaceutical Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406548
- Sponsor's protocol ID
- CBPS804A2203
- Status last verified
- Sep 2022
- First submitted
- 11 Jul 2011
- Last updated
- 15 Sep 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Assess the Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density
- ClinicalTrials.gov ID
- NCT01406548
- Acronym / sponsor ID
- CBPS804A2203
- Conditions
- Osteopenia, Osteoporosis
- Keywords
- Osteopenia, osteoporosis, low bone mineral density
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ultragenyx Pharmaceutical IncIndustry (pharma, biotech, devices)
- Collaborators
- Mereo BioPharma, Novartis
- Study start
- Jul 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 1 Aug 2011 (estimated)
- 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.
This study is designed to provide information on the safety, tolerability, pharmacokinetics (PK) and bone biomarker response following multiple BPS804 administration in multiple dosing regimens. This information will permit a comparison of the possible risks and benefits of different dosing regimens of the study drug to enable optimal doses and dose intervals to be tested in subsequent studies.
Detailed description
This study was conducted and previously posted by Novartis. The record was transferred to Ultragenyx in February 2021.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BPS804 dosing frequency 1 | Experimental | Drug: BPS804 20mg/KgSubjects dosed 20mg/Kg BPS804 monthly |
| placebo dosing frequency 1 | Placebo comparator | Drug: Placebo to 20mg/Kg BPS804Subjects dosed with matching placebo to 20mg/Kg BPS804 monthly |
| BPS804 dosing frequency 2 | Experimental | Drug: BPS804 20mg/KgSubjects dosed with 20mg/Kg BPS804 quarterly |
| placebo dosing frequency 2 | Placebo comparator | Drug: Placebo to 20mg/Kg BPS804Subjects dosed with matching placebo to 20mg/Kg BPS804 every 3 months |
| BPS804 dosing frequency 3 | Experimental | Drug: BPS804 20mg/KgSubjects dosed with 20mg/Kg BPS804 weekly |
| Placebo dosing frequency 3 | Placebo comparator | Drug: Placebo to 20mg/Kg BPS804Subjects dosed with matching placebo to 20mg/Kg BPS804 weekly |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal women (natural or surgically induced menopause)
- Low bone mineral density (BMD), as defined by a T score or equivalent BMD absolute value (g/cm2) for lumbar spine of between -2.0 and -3.5, inclusive
- Body mass index (BMI) must be within the range of 18 to 35kg/m2. Subjects must weigh between 45 and 120kg inclusive to participate.
- 25-(OH) vitamin D serum level of ≥ 15ng/ml
- Serum calcium within normal limits
Key exclusion criteria (11 listed)
- Subjects with suspected neural foraminal stenosis (e.g., cervical, spinal, lumbar), or history of Bell's palsy, cranial nerve disorders, temporomandibular joint and muscle disorders.
- Subjects who have an increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained and clinically significant elevations of alkaline phosphatase and/or subjects who have received radiation therapy involving the skeleton.
- Subjects with any known bone diseases other than postmenopausal osteoporosis.
- Subjects with a history of an osteoporotic fracture (e.g., vertebral fracture, fragility fracture of the wrist, radius, humerus, hip, or pelvis).
- Subjects who are regularly using or have regularly used agents affecting bone metabolism:
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 |
|---|---|---|
| BPS804 20mg/Kg | Drug | BPS804 dosing frequency 1, BPS804 dosing frequency 2, BPS804 dosing frequency 3 |
| Placebo to 20mg/Kg BPS804 | Drug | Placebo dosing frequency 3, placebo dosing frequency 1, placebo dosing frequency 2 |
Primary outcome
Change from baseline to month 9 in bone mineral density at the lumbar spine for the individual BPS804 groups and pooled placebo arms.
Time frame: 9 months
The number (percent) of subjects experiencing adverse events or serious adverse events
Time frame: 9 months
5 secondary outcomes
Change from baseline during 9 months of serological bone biomarkers for the individual BPS804 groups and pooled placebo arms.
Time frame: 9 months
Characterization of the PK profile of BPS804: area under the plasma concentration-time curve (AUC)
Time frame: 260 days
Characterization of the PK profile of BPS804: time to reach the maximum Characterization of the PK profile of BPS804: maximum plasma concentration (Cmax)
Time frame: 260 days
Characterization of the PK profile: time to reach the maximum concentration (Tmax)
Time frame: 260 days
Characterization of the PK profile of BPS804: half-life (T1/2)
Time frame: 260 days
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 15 Sep 2022.
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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.
Medical Director study director
Ultragenyx Pharmaceutical Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BPS804 20mg/Kg in people with Osteopenia and Osteoporosis, run by Ultragenyx Pharmaceutical Inc at 5 sites in United States.
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 5 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: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline to month 9 in bone mineral density at the lumbar spine for the individual BPS804 groups and pooled placebo arms. (time frame: 9 months). The study lists 2 primary outcomes in all. 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 15 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.