Hypoparathyroidism
Conditions
Keywords
PTH 1-84, Hypoparathyroidism, Parathyroid Hormone 1-84, NPSP558
Brief summary
This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.
Detailed description
Patients with a history of Hypoparathyroidism will be enrolled to receive study drug for up to 80 months, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured.
Interventions
DRUGNPSP558
All patients will inject NPSP558 individual titration of 25, 50, 75 or 100 μg SC QD into alternating thighs in the morning via a multidose injection pen device.
Sponsors
Shire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Previously completed the rhPTH\[1-84\] RELAY study (8 weeks of active therapy) and/or previously completed the rhPTH\[1-84\] REPLACE study (Visit 18). * Able to perform daily SC self-injections of study medication (or have a designee perform injection). * Women who are (1) postmenopausal; (2) surgically sterilized; or, (3) of childbearing potential with a negative pregnancy test and who consent to use two acceptable methods of contraception for the duration of the study. * Males who have female partners of childbearing potential must use two acceptable forms of contraception for the duration of the study. * Serum creatinine \<1.5 mg/dL at enrollment. * Total serum calcium less than or equal to upper limit of normal (ULN) based on local laboratory result prior to enrollment. * Serum 25 hydroxy (OH) vitamin D less than or equal to 1.5 times the ULN within approximately 16 weeks prior to enrollment.
Exclusion criteria
* Any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of parathyroid hormone (PTH). * Pregnant or lactating women. * Any disease or condition which has a high probability of precluding the subject from completing the study or where the subject cannot or will not appropriately comply with study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) | From start of study drug administration up to follow-up (82 months) | SAE is an adverse event (AE) that results in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical or medicinal product. Treatment emergent adverse events (TEAEs) were defined as AEs whose onset occurs, severity worsens or intensity increases after receiving the study medication of this study and \<= 30 days after last dose of study drug. |
| Number of Responders With Calcium Source at Week 52 | Week 52 | A responder was defined as a participant who met all of the following 3 criteria at each (1) a greater than (\>) 50% reduction from baseline or less than (\<) 500 milligram (mg) of daily calcium supplementation. (2) a \>50% reduction from baseline or \<0.25 microgram (mcg) of daily calcitriol supplementation. (3) an albumin-corrected total serum calcium concentration that was normalized or maintained compared to the baseline greater than or equal to (\>=) 1.875 millimoles per liter (mmol/L) and not exceeding the Upper Limit of Normal (ULN) values (2.15 to 2.55 mmol/L). End of Treatment (EOT) was defined as the last determination of response or last available measurement during the treatment period. Number of responders with calcium source for citrate and carbonate at week 52 was reported here. |
| Number of Responders With Calcium Source at End Of Treatment (EOT) (Up to 82 Months) | EOT (up to 82 months) | A responder was defined as a participant who met all of the following 3 criteria at each (1) a greater than (\>) 50% reduction from baseline or less than (\<) 500 milligram (mg) of daily calcium supplementation. (2) a \>50% reduction from baseline or \<0.25 microgram (mcg) of daily calcitriol supplementation. (3) an albumin-corrected total serum calcium concentration that was normalized or maintained compared to the baseline greater than or equal to (\>=) 1.875 millimoles per liter (mmol/L) and not exceeding the Upper Limit of Normal (ULN) values (2.15 to 2.55 mmol/L). End of Treatment (EOT) was defined as the last determination of response or last available measurement during the treatment period. Number of responders with calcium source for citrate and carbonate at EOT was reported here. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 24-Hour Urine Calcium Excretion Through EOT (Up to 82 Months) | Baseline, EOT (up to 82 months) | Change in 24 hour urine calcium excretion was reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| Change From Baseline in 24-hour Urine Calcium Excretion in Participants Who Used Calcium-Sparing Diuretics Through EOT (Up to 82 Months) | Baseline, EOT (up to 82 months) | Change from baseline in urinary calcium concentration in participants who used at least one calcium-sparing diuretics and participants who not used calcium-sparing diuretics were reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| Change From Baseline in Serum Calcium Concentration in Participants Who Used and Calcium Sparing Diuretics at EOT (Upto 82 Months) | Baseline, EOT (upto 82 months) | Change in serum calcium concentration of the number of participants who used at least one calcium-sparing diuretics and not used calcium sparing diuretics were reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| Change From Baseline in Serum Phosphate at Month 72 and EOT (Upto 82 Months) | Baseline, Month 72, EOT (upto 82 months) | Change of serum phosphate from baseline were reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| Percent Change From Baseline in Oral Calcium Supplementation at Week 52 and EOT (Up to 82 Months) | Baseline, Week 52 and EOT (up to 82 months) | Percent change from baseline of oral calcium supplementation were reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| Change From Baseline in Bone Turnover Markers at EOT (Up to 82 Months) | Baseline, EOT (up to 82 months) | Bone Turnover Markers such as bone specific alkaline phosphatase (BSAP), serum procollagen type 1 amino-terminal propeptide (P1NP) , osteocalcin were reported in particpiants. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| Change From Baseline in Serum Carboxy Terminal Telopeptide of Type I Collagen (s-CTx) Bone Turnover Marker at EOT (Up to 82 Months) | Baseline, EOT (up to 82 months) | Change form baseline in bone turnover marker (s-CTx)was reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Baseline, Week 52 and EOT (up to 82 months) | Change from baseline in BMD of lumbar spine (L1-L4), hip-total, hip-trochanter, hip-intertrochanter, hip-ward's triangle, hip-femoral neck, distal one third radius at Week 52 then every 12 months until EOT were assessed by dual-energy X-ray absorptiometry \[DXA\] and Z-score. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| Number of Participants Who Maintained a Calcium Phosphate Product in A Normal Range at EOT (Up to 82 Months) | EOT (up to 82 months) | The normal range of calcium phosphate product is defined as \<= 4.441 millimoles square per liter square (mmol\^2/L\^2). |
| Percent Change From Baseline in Oral Calcitriol Supplementation at Week 52 and EOT (Up to 82 Months) | Baseline, Week 52 and EOT (up to 82 months) | Percent change from baseline of oral calcitriol supplementation were reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
| Percent Change From Baseline in Albumin Corrected Total Serum Calcium (ACSC) at EOT (Up to 82 Months) | Baseline, EOT (up to 82 months) | Percent change in ACSC was reported. EOT was defined as the last determination of response or last available measurement during the treatment period. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 12 study centers in the United States between 06 April 2011 (first participant first visit) and 08 June 2018 (last participant last visit).
Pre-assignment details
A total of 51 participants were enrolled and 49 participants received treatment out of them 37 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| rhPTH (1-84) Participants received rhPTH (1-84) subcutaneous injection with a starting dose of 25 or 50 microgram (mcg) once daily with dose adjusted by the investigator with upwards in increments of 25 mcg up to 100 mcg daily, with the goal to achieve or maintain total serum calcium levels in the range of 8.0 to 9.0 milligrams per deciliter (mg/dL). | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Eligibility failure | 2 |
| Overall Study | Investigator Decision | 2 |
| Overall Study | Participant not entering extensionperiod | 1 |
| Overall Study | Screen failure | 2 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | rhPTH (1-84) |
|---|---|
| Age, Continuous | 48.1 Years STANDARD_DEVIATION 9.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 49 |
| other Total, other adverse events | 48 / 49 |
| serious Total, serious adverse events | 13 / 49 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)
SAE is an adverse event (AE) that results in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical or medicinal product. Treatment emergent adverse events (TEAEs) were defined as AEs whose onset occurs, severity worsens or intensity increases after receiving the study medication of this study and \<= 30 days after last dose of study drug.
Time frame: From start of study drug administration up to follow-up (82 months)
Population: Safety population included all enrolled participants who received at least 1 dose of study drug and had post baseline safety data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| rhPTH (1-84) | Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) | Number of participants with TESAE | 13 Participants |
| rhPTH (1-84) | Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) | Number of participants with TEAE | 48 Participants |
Primary
Number of Responders With Calcium Source at End Of Treatment (EOT) (Up to 82 Months)
A responder was defined as a participant who met all of the following 3 criteria at each (1) a greater than (\>) 50% reduction from baseline or less than (\<) 500 milligram (mg) of daily calcium supplementation. (2) a \>50% reduction from baseline or \<0.25 microgram (mcg) of daily calcitriol supplementation. (3) an albumin-corrected total serum calcium concentration that was normalized or maintained compared to the baseline greater than or equal to (\>=) 1.875 millimoles per liter (mmol/L) and not exceeding the Upper Limit of Normal (ULN) values (2.15 to 2.55 mmol/L). End of Treatment (EOT) was defined as the last determination of response or last available measurement during the treatment period. Number of responders with calcium source for citrate and carbonate at EOT was reported here.
Time frame: EOT (up to 82 months)
Population: ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| rhPTH (1-84) | Number of Responders With Calcium Source at End Of Treatment (EOT) (Up to 82 Months) | Citrate (Responder) | 7 Participants |
| rhPTH (1-84) | Number of Responders With Calcium Source at End Of Treatment (EOT) (Up to 82 Months) | Carbonate (Responder) | 20 Participants |
Primary
Number of Responders With Calcium Source at Week 52
A responder was defined as a participant who met all of the following 3 criteria at each (1) a greater than (\>) 50% reduction from baseline or less than (\<) 500 milligram (mg) of daily calcium supplementation. (2) a \>50% reduction from baseline or \<0.25 microgram (mcg) of daily calcitriol supplementation. (3) an albumin-corrected total serum calcium concentration that was normalized or maintained compared to the baseline greater than or equal to (\>=) 1.875 millimoles per liter (mmol/L) and not exceeding the Upper Limit of Normal (ULN) values (2.15 to 2.55 mmol/L). End of Treatment (EOT) was defined as the last determination of response or last available measurement during the treatment period. Number of responders with calcium source for citrate and carbonate at week 52 was reported here.
Time frame: Week 52
Population: ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| rhPTH (1-84) | Number of Responders With Calcium Source at Week 52 | Citrate (Responder) | 7 Participants |
| rhPTH (1-84) | Number of Responders With Calcium Source at Week 52 | Carbonate (Responder) | 21 Participants |
Secondary
Change From Baseline in 24-hour Urine Calcium Excretion in Participants Who Used Calcium-Sparing Diuretics Through EOT (Up to 82 Months)
Change from baseline in urinary calcium concentration in participants who used at least one calcium-sparing diuretics and participants who not used calcium-sparing diuretics were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
Time frame: Baseline, EOT (up to 82 months)
Population: ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| rhPTH (1-84) | Change From Baseline in 24-hour Urine Calcium Excretion in Participants Who Used Calcium-Sparing Diuretics Through EOT (Up to 82 Months) | EOT: Participants used calcium sparing diuretics | -4.07 Millimoles per day (mmol/day) | Standard Deviation 6 |
| rhPTH (1-84) | Change From Baseline in 24-hour Urine Calcium Excretion in Participants Who Used Calcium-Sparing Diuretics Through EOT (Up to 82 Months) | EOT:Participants without calcium sparing diuretics | -1.79 Millimoles per day (mmol/day) | Standard Deviation 5.713 |
Secondary
Change From Baseline in 24-Hour Urine Calcium Excretion Through EOT (Up to 82 Months)
Change in 24 hour urine calcium excretion was reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
Time frame: Baseline, EOT (up to 82 months)
Population: ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| rhPTH (1-84) | Change From Baseline in 24-Hour Urine Calcium Excretion Through EOT (Up to 82 Months) | Baseline | 8.92 Millimoles per day (mmol/day) | Standard Deviation 5.009 |
| rhPTH (1-84) | Change From Baseline in 24-Hour Urine Calcium Excretion Through EOT (Up to 82 Months) | Change from Baseline at EOT | -2.37 Millimoles per day (mmol/day) | Standard Deviation 5.809 |
Secondary
Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months)
Change from baseline in BMD of lumbar spine (L1-L4), hip-total, hip-trochanter, hip-intertrochanter, hip-ward's triangle, hip-femoral neck, distal one third radius at Week 52 then every 12 months until EOT were assessed by dual-energy X-ray absorptiometry \[DXA\] and Z-score. EOT was defined as the last determination of response or last available measurement during the treatment period.
Time frame: Baseline, Week 52 and EOT (up to 82 months)
Population: ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| rhPTH (1-84) | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Lumbar Spine (L1-L4) - Change at Week 52 | -0.0156 gram per square centimeter (g/cm^2) | Standard Deviation 0.0891 |
| rhPTH (1-84) | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Lumbar spine (L1-L4) - Change at EOT | -0.0272 gram per square centimeter (g/cm^2) | Standard Deviation 0.1111 |
| rhPTH (1-84) | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Hip - Total - Change at Week 52 | -0.0189 gram per square centimeter (g/cm^2) | Standard Deviation 0.0572 |
| rhPTH (1-84) | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Hip - Total - Change at EOT | -0.0329 gram per square centimeter (g/cm^2) | Standard Deviation 0.0747 |
| rhPTH (1-84) | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Hip - Femoral Neck - Change at Week 52 | -0.0278 gram per square centimeter (g/cm^2) | Standard Deviation 0.0553 |
| rhPTH (1-84) | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Hip - Femoral Neck - Change at EOT | -0.0364 gram per square centimeter (g/cm^2) | Standard Deviation 0.0848 |
| rhPTH (1-84) | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Hip - Trochanter - Change at Week 52 | -0.0235 gram per square centimeter (g/cm^2) | Standard Deviation 0.0542 |
| rhPTH (1-84) | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Hip - Trochanter- Change at EOT | -0.0236 gram per square centimeter (g/cm^2) | Standard Deviation 0.1018 |
| rhPTH (1-84) | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Hip - Ward's Triangle - Change at Week 52 | -0.0081 gram per square centimeter (g/cm^2) | Standard Deviation 0.0827 |
| rhPTH (1-84) | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Hip - Ward's Triangle - Change at EOT | -0.0178 gram per square centimeter (g/cm^2) | Standard Deviation 0.1014 |
| rhPTH (1-84) | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Distal One Third Radius - Change at Week 52 | -0.0006 gram per square centimeter (g/cm^2) | Standard Deviation 0.0629 |
| rhPTH (1-84) | Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) | Distal One Third Radius - Change at EOT | -0.0368 gram per square centimeter (g/cm^2) | Standard Deviation 0.0895 |
Secondary
Change From Baseline in Bone Turnover Markers at EOT (Up to 82 Months)
Bone Turnover Markers such as bone specific alkaline phosphatase (BSAP), serum procollagen type 1 amino-terminal propeptide (P1NP) , osteocalcin were reported in particpiants. EOT was defined as the last determination of response or last available measurement during the treatment period.
Time frame: Baseline, EOT (up to 82 months)
Population: ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| rhPTH (1-84) | Change From Baseline in Bone Turnover Markers at EOT (Up to 82 Months) | EOT: Bone Specific alkaline phosphatase | 5.27 Microgram per liter (μg/L) | Standard Deviation 11.156 |
| rhPTH (1-84) | Change From Baseline in Bone Turnover Markers at EOT (Up to 82 Months) | EOT: P1NP | 91.85 Microgram per liter (μg/L) | Standard Deviation 104.327 |
| rhPTH (1-84) | Change From Baseline in Bone Turnover Markers at EOT (Up to 82 Months) | EOT: Osteocalcin | 10.06 Microgram per liter (μg/L) | Standard Deviation 11.57 |
Secondary
Change From Baseline in Serum Calcium Concentration in Participants Who Used and Calcium Sparing Diuretics at EOT (Upto 82 Months)
Change in serum calcium concentration of the number of participants who used at least one calcium-sparing diuretics and not used calcium sparing diuretics were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
Time frame: Baseline, EOT (upto 82 months)
Population: ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| rhPTH (1-84) | Change From Baseline in Serum Calcium Concentration in Participants Who Used and Calcium Sparing Diuretics at EOT (Upto 82 Months) | EOT: Participants used calcium sparing diuretics | -0.21 Millimoles per liter (mmol/L) | Standard Deviation 0.194 |
| rhPTH (1-84) | Change From Baseline in Serum Calcium Concentration in Participants Who Used and Calcium Sparing Diuretics at EOT (Upto 82 Months) | EOT:Participants without calcium sparing diuretics | -0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.2 |
Secondary
Change From Baseline in Serum Carboxy Terminal Telopeptide of Type I Collagen (s-CTx) Bone Turnover Marker at EOT (Up to 82 Months)
Change form baseline in bone turnover marker (s-CTx)was reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
Time frame: Baseline, EOT (up to 82 months)
Population: ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rhPTH (1-84) | Change From Baseline in Serum Carboxy Terminal Telopeptide of Type I Collagen (s-CTx) Bone Turnover Marker at EOT (Up to 82 Months) | 224.21 Nanogram per liter (ng/L) | Standard Deviation 295.858 |
Secondary
Change From Baseline in Serum Phosphate at Month 72 and EOT (Upto 82 Months)
Change of serum phosphate from baseline were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
Time frame: Baseline, Month 72, EOT (upto 82 months)
Population: ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| rhPTH (1-84) | Change From Baseline in Serum Phosphate at Month 72 and EOT (Upto 82 Months) | Change from Baseline at Month 72 | -0.309 Millimoles per day (mmol/day) | Standard Deviation 0.228 |
| rhPTH (1-84) | Change From Baseline in Serum Phosphate at Month 72 and EOT (Upto 82 Months) | Change from Baseline at EOT | -0.254 Millimoles per day (mmol/day) | Standard Deviation 0.2924 |
Secondary
Number of Participants Who Maintained a Calcium Phosphate Product in A Normal Range at EOT (Up to 82 Months)
The normal range of calcium phosphate product is defined as \<= 4.441 millimoles square per liter square (mmol\^2/L\^2).
Time frame: EOT (up to 82 months)
Population: ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rhPTH (1-84) | Number of Participants Who Maintained a Calcium Phosphate Product in A Normal Range at EOT (Up to 82 Months) | 49 Count of participants |
Secondary
Percent Change From Baseline in Albumin Corrected Total Serum Calcium (ACSC) at EOT (Up to 82 Months)
Percent change in ACSC was reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
Time frame: Baseline, EOT (up to 82 months)
Population: ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rhPTH (1-84) | Percent Change From Baseline in Albumin Corrected Total Serum Calcium (ACSC) at EOT (Up to 82 Months) | -0.03 Percent change in ACSC | Standard Deviation 0.19 |
Secondary
Percent Change From Baseline in Oral Calcitriol Supplementation at Week 52 and EOT (Up to 82 Months)
Percent change from baseline of oral calcitriol supplementation were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
Time frame: Baseline, Week 52 and EOT (up to 82 months)
Population: ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| rhPTH (1-84) | Percent Change From Baseline in Oral Calcitriol Supplementation at Week 52 and EOT (Up to 82 Months) | Percent change from baseline at Week 52 | -72.024 %changeoforal calcitriol supplementation | Standard Deviation 44.6232 |
| rhPTH (1-84) | Percent Change From Baseline in Oral Calcitriol Supplementation at Week 52 and EOT (Up to 82 Months) | Percent change from baseline at EOT | -73.737 %changeoforal calcitriol supplementation | Standard Deviation 39.3461 |
Secondary
Percent Change From Baseline in Oral Calcium Supplementation at Week 52 and EOT (Up to 82 Months)
Percent change from baseline of oral calcium supplementation were reported. EOT was defined as the last determination of response or last available measurement during the treatment period.
Time frame: Baseline, Week 52 and EOT (up to 82 months)
Population: ITT population included participants who received at least one dose of study drug and had at least one efficacy measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| rhPTH (1-84) | Percent Change From Baseline in Oral Calcium Supplementation at Week 52 and EOT (Up to 82 Months) | Percent change from baseline at Week 52 | -68.7 % change of oral calcium supplementation | Standard Deviation 34.07 |
| rhPTH (1-84) | Percent Change From Baseline in Oral Calcium Supplementation at Week 52 and EOT (Up to 82 Months) | Percent change from baseline at EOT | -39.4 % change of oral calcium supplementation | Standard Deviation 107.23 |