Postmenopausal OsteoporosisPhase 1/2NCT03720886
G56W1 in Women With Postmenopausal Osteoporosis
A Phase 1/2 study testing rhPTH（1-34） 28.2μg, rhPTH（1-34） 56.5μg and teriparatide acetate(Teribone™) in people with Postmenopausal Osteoporosis, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 9 sites in China.
Trial summary
This study will assess the pharmacokinetics and safety and explore therapeutic effects with once-weekly recombinant human parathyroid hormone for injection ( 1-34 ) ( G56W1 ) in women with post-menopausal osteoporosis .The anticipated time on study treatment is 24 weeks, and the target sample size is 148 individuals. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- rhPTH（1-34） 28.2μg, rhPTH（1-34） 56.5μg and teriparatide acetate(Teribone™)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 9 sitesChina
- Study dates
- 1 Oct 2018to 31 Aug 2020
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, capable of self - motivation , 45 years old ≤ age ≤ 75 years old.
- Natural menopause for 3 years or more; or surgical menopause for 3 years or more (surgery needs to be performed after 40 years old), for women with surgical menopause, estradiol(E2)< 25 pg/ml and follicle stimulating hormone(FSH) > 40mIU/ml should be met.
- Weight ≥ 40kg , 18 ≤ body mass index(BMI)≤ 30 .
- Meets one of the following diagnostic criteria for osteoporosis, and ≥ 3 vertebral bodies of L1-4 can be measured by bone mineral density using the DXA method.
- Brittle fracture of the hip or vertebral body, and the bone density measurement T- score< -1.0.
- The T- score of the central axis bone mineral density or the 1/3 bone density of the distal radius of the tibia was ≤-2.5 measured by DXA .
- Bone density measurements were consistent with low bone mass ( -2.5 < T- value < -1.0 ) and combined with proximal humerus, pelvic or forearm distal brittle fractures.
- to participate in the trial and sign the informed consent form.
Who cannot join
- to have diseases affecting calcium or bone metabolism that are not effectively controlled, such as primary hyperparathyroidism or hyperthyroidism, Paget's bone disease, hypercalcemia, hypocalcemia, active urolithiasis.
- Secondary osteoporosis, such as osteomalacia, rheumatoid arthritis, gout, multiple myeloma, etc.
- Severe lumbar anatomical abnormalities which affecting DXA bone mineral density measurement, such as severe scoliosis.
- Patients who have been treated for anti-osteoporosis before random enrollment:
- Patients who received parathyroid hormone(PTH) therapy before random enrollment (including clinical trials of similar products).
- Patients who received bisphosphonate injection within 1 year prior to random enrollment or received bisphosphonate oral administration within 3 months for > 2 weeks prior to enrollment.
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- Systemic treatment of androgen, estrogen, and selective estrogen receptor modulator(SERM) preparations within 3 months > 2 weeks prior to random enrollment.
- Three months before randomized to receive of heparin, warfarin, anticonvulsants (except benzodiazepines), digoxin accumulated for> 2 weeks.
- In the 3 months prior to random enrollment , received calcitonin, vitamin K preparation, active vitamin D3 preparation, oral or intravenous glucocorticoid treatment for > 4 weeks.
- Suffering from severe kidney disease, uncontrolled high blood pressure ( ≥150/100 mmHg ), symptomatic ischemic heart disease, cerebral infarction or obliterative atherosclerosis, malignancy, and other serious underlying diseases.
- Laboratory tests indicates abnormal, including any of the following indicators abnormalities (according to the normal range of each center, after consideration of the investigator with clinical considerations, such as caused by operational procedures, etc., after discussion with the sponsor, may allow retesting once) .
- Alkaline phosphatase(ALP)>1.5 times the upper limit of normal.
- Aspartate transaminase(AST) or alanine aminotransferase(ALT) or total bilirubin(TBIL) > 2.0 times the upper limit of normal.
- Glycated hemoglobin(HbA1c )≥ 7.0% .
- White blood cell(WBC)< 3.5×10^9 /L , Hb<100g/L or Plt<90×10^9 /L.
- Thyroid-stimulating hormone(TSH)<0.01 mIU/L (mU/L) or TSH>10 mIU/L (mU/L) .
- Parathyroid hormone(PTH)>1.5 times the upper limit of normal.
- Serum creatinine(SCr)>1.2 times the upper limit of normal.
- Serum total calcium(SCa)> normal upper limit.
- Subjects who had significant clinical significance including HIV , hepatitis B, hepatitis C, and syphilis ( hepatitis B virus carriers can be enrolled ) .
- Heavy Smoking (average of more than 10 / day) and / or alcohol addicted (converted to pure alcohol 30 ml / day or more) .
- Recent drug abuse or drug dependence evidence.
- Those who are allergic to test drugs / control drugs or biological products.
- Included in other interventional clinical trials within 3 months of the study.
- Been undergone radiation therapy for bones.
- Mental illness or any cause of cognitive impairment.
- Patients who were considered unsuitable for the study based on risk benefits by investigators.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100006
The West China Second UniversityHospital of Sichuan University
Chengdu, Sichuan
West China Hospital，Sichuan University
Chengdu, Sichuan
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Zhongda Hospital, Southeast University
Nanjing, Jiangsu
Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200000
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
Tianjin Hospital
Tianjin, Tianjin Municipality
Chongqing Three Gorges Central Hospital
Wanzhou, Chongqing Municipality
About this study
Official title: Two-dose, Positive Drug Control, Multicentre, Randomized, Double-blind Study of Recombinant Human Parathyroid Hormone for Injection(rhPTH)(1-34) Once a Week to Treat Postmenopausal Osteoporosis Women for the Evaluation the Pharmacokinetics and Safety and to Explore Therapeutic Effects
This study will assess the pharmacokinetics and safety and explore therapeutic effects with once-weekly recombinant human parathyroid hormone for injection ( 1-34 ) ( G56W1 ) in women with post-menopausal osteoporosis .The anticipated time on study treatment is 24 weeks, and the target sample size is 148 individuals.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- rhPTH（1-34） 28.2μg, rhPTH（1-34） 56.5μg, teriparatide acetate(Teribone™)
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhPTH（1-34） 28.2μgBiological
Also called G56W1
Administered by subcutaneous injection
rhPTH（1-34） 56.5μgBiological
Also called G56W1
Administered by subcutaneous injection
teriparatide acetate(Teribone™)Biological
Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| rhPTH（1-34） 28.2μg | Experimental | Participants received 28.2μg rhPTH（1-34）administered by subcutaneous injection once a week for 24 weeks. Receives: Biological: rhPTH（1-34） 28.2μg |
| rhPTH（1-34） 56.5μg | Experimental | Participants received 56.5μg rhPTH（1-34）administered by subcutaneous injection once a week for 24 weeks. Receives: Biological: rhPTH（1-34） 56.5μg |
| teriparatide acetate(Teribone™) | Active comparator | Participants received 56.5μg teriparatide acetate(Teribone™) administered by subcutaneous injection once a week for 24 weeks. Receives: Biological: teriparatide acetate(Teribone™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change in bone density of the lumbar spine ( L1-4 ) from baseline to 24 weeks after treatment
bone mineral density(BMD) measured by dual energy x-ray absorptiometry (DXA)
Measured: Baseline，week 24
Secondary outcomes (6)
Evaluate the rate of change of Procollagen I N-terminal peptide(PINP),Serum cross-linked C-terminal telopeptide of type I collagen(s-CTX) ,Bone alkaline phosphatase(BALP) , and blood calcium from baseline
Central lab will be used
Measured: Baseline，week 24
The percentage change of total hip bone density from baseline to 24 weeks after G56W1 treatment
BMD measured by DXA
Measured: Baseline，week 24
Maximum plasma concentration (Cmax)
serum parathyroid hormone(PTH) will be tested for all pharmacokinetics parameters
Measured: Baseline，week 1，week 4，week 12，week 24
Area under the plasma concentration versus time curve (AUC)
serum PTH will be tested for all pharmacokinetics parameters
Measured: Baseline，week 1，week 4，week 12，week 24
Time to maximum plasma concentration（Tmax）
serum PTH will be tested for all pharmacokinetics parameters
Measured: Baseline，week 1，week 4，week 12，week 24
Elimination half-life（t1/2）
serum PTH will be tested for all pharmacokinetics parameters
Measured: Baseline，week 1，week 4，week 12，week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Oct 2018
- Primary completion31 May 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weibo Xia, Prof., Principal investigator, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720886
- Sponsor's protocol ID
- G56W1A201
- Status last verified
- Oct 2018
- First submitted
- 14 Oct 2018
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- 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 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-dose, Positive Drug Control, Multicentre, Randomized, Double-blind Study of Recombinant Human Parathyroid Hormone for Injection(rhPTH)(1-34) Once a Week to Treat Postmenopausal Osteoporosis Women for the Evaluation the Pharmacokinetics and Safety and to Explore Therapeutic Effects
- ClinicalTrials.gov ID
- NCT03720886
- Acronym / sponsor ID
- G56W1A201
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 25 Oct 2018 (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.
This study will assess the pharmacokinetics and safety and explore therapeutic effects with once-weekly recombinant human parathyroid hormone for injection ( 1-34 ) ( G56W1 ) in women with post-menopausal osteoporosis .The anticipated time on study treatment is 24 weeks, and the target sample size is 148 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rhPTH（1-34） 28.2μg | Experimental | Biological: rhPTH（1-34） 28.2μgParticipants received 28.2μg rhPTH（1-34）administered by subcutaneous injection once a week for 24 weeks. |
| rhPTH（1-34） 56.5μg | Experimental | Biological: rhPTH（1-34） 56.5μgParticipants received 56.5μg rhPTH（1-34）administered by subcutaneous injection once a week for 24 weeks. |
| teriparatide acetate(Teribone™) | Active comparator | Biological: teriparatide acetate(Teribone™)Participants received 56.5μg teriparatide acetate(Teribone™) administered by subcutaneous injection once a week for 24 weeks. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female, capable of self - motivation , 45 years old ≤ age ≤ 75 years old.
- Natural menopause for 3 years or more; or surgical menopause for 3 years or more (surgery needs to be performed after 40 years old), for women with surgical menopause, estradiol(E2)< 25 pg/ml and follicle stimulating hormone(FSH) > 40mIU/ml should be met.
- Weight ≥ 40kg , 18 ≤ body mass index(BMI)≤ 30 .
- Meets one of the following diagnostic criteria for osteoporosis, and ≥ 3 vertebral bodies of L1-4 can be measured by bone mineral density using the DXA method.
- to participate in the trial and sign the informed consent form.
Key exclusion criteria (27 listed)
- to have diseases affecting calcium or bone metabolism that are not effectively controlled, such as primary hyperparathyroidism or hyperthyroidism, Paget's bone disease, hypercalcemia, hypocalcemia, active urolithiasis.
- Secondary osteoporosis, such as osteomalacia, rheumatoid arthritis, gout, multiple myeloma, etc.
- Severe lumbar anatomical abnormalities which affecting DXA bone mineral density measurement, such as severe scoliosis.
- Patients who have been treated for anti-osteoporosis before random enrollment:
- Suffering from severe kidney disease, uncontrolled high blood pressure ( ≥150/100 mmHg ), symptomatic ischemic heart disease, cerebral infarction or obliterative atherosclerosis, malignancy, and other serious underlying diseases.
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 |
|---|---|---|
| rhPTH（1-34） 28.2μgAlso: G56W1Administered by subcutaneous injection | Biological | rhPTH（1-34） 28.2μg |
| rhPTH（1-34） 56.5μgAlso: G56W1Administered by subcutaneous injection | Biological | rhPTH（1-34） 56.5μg |
| teriparatide acetate(Teribone™)Administered by subcutaneous injection | Biological | teriparatide acetate(Teribone™) |
Primary outcome
The percentage change in bone density of the lumbar spine ( L1-4 ) from baseline to 24 weeks after treatment
Time frame: Baseline，week 24
bone mineral density(BMD) measured by dual energy x-ray absorptiometry (DXA)
6 secondary outcomes
Evaluate the rate of change of Procollagen I N-terminal peptide(PINP),Serum cross-linked C-terminal telopeptide of type I collagen(s-CTX) ,Bone alkaline phosphatase(BALP) , and blood calcium from baseline
Time frame: Baseline，week 24
The percentage change of total hip bone density from baseline to 24 weeks after G56W1 treatment
Time frame: Baseline，week 24
Maximum plasma concentration (Cmax)
Time frame: Baseline，week 1，week 4，week 12，week 24
Area under the plasma concentration versus time curve (AUC)
Time frame: Baseline，week 1，week 4，week 12，week 24
Time to maximum plasma concentration（Tmax）
Time frame: Baseline，week 1，week 4，week 12，week 24
Elimination half-life（t1/2）
Time frame: Baseline，week 1，week 4，week 12，week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- 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.
Weibo Xia, Prof. principal investigator
Peking Union Medical College
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing rhPTH（1-34） 28.2μg, rhPTH（1-34） 56.5μg and teriparatide acetate(Teribone™) in people with Postmenopausal Osteoporosis, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 9 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 8 inclusion and 27 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 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
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 percentage change in bone density of the lumbar spine ( L1-4 ) from baseline to 24 weeks after treatment (time frame: Baseline，week 24). 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 25 Oct 2018.