Trial · NCT03324880

A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)

NCT03324880, Phase 4, Completed, Shire; results first posted 2023-06-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE). Trials, record NCT03324880. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03324880

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)
NCT number: NCT03324880
Status: Completed
Phases: Phase 4
Enrollment: 93 participants, actual
Lead sponsor: Shire
Conditions: Hypoparathyroidism
Interventions: rhPTH (1-84), Placebo
First posted: 2017-10-30
Last updated: 2023-06-09
Other registries' IDs: eudract:2017-000284-32
Results first posted: 2023-06-09

Source ClinicalTrials.gov

Registered outcomes29

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Subscale Score at Week 26	Baseline, Week 26	The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The symptom subscale score was computed as the average of symptom items 1-7 scores with more than 3 of the 7 symptom item scores were non-missing. Negative change in scores indicates improvement. A mixed model for repeated measures (MMRM) was used for analysis.
Secondary	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 26	Baseline, Week 26	The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire contains 13 fatigue-related questions. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 5-point Likert scale, where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Very much. Thus, the total score ranges from 0 to 52. High scores represent less fatigue. A MMRM was used for analysis.
Secondary	Change From Baseline in Physical Component Summary (PCS) Derived From 36-Item Short Form Health Survey Version 2 (SF-36v2) Scores at Week 26	Baseline, Week 26	The SF-36 is a validated instrument that questions participants about perceived physical and mental health and function. The SF-36 consists of 8 scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight; the lower the score the more disability. Change in PCS derived from SF-36v2 at Week 26 was reported. A MMRM was used for analysis.
Secondary	Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Impact Subscale Score at Week 26	Baseline, Week 26	The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The impact subscale score was computed as the average of impact items 10-13 scores with no impact item score was non-missing. Negative change in scores indicates improvement. A MMRM was used for analysis.
Secondary	Change From Baseline in Individual Hypoparathyroidism Symptom Diary (HypoPT-SD) Impact Items Score at Week 26	Baseline, Week 26	The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The change in individual symptom item scores was reported. Negative change in scores indicates improvement. MMRM was used for analysis.
Secondary	Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Anxiety (Item 8) Score at Week 26	Baseline, Week 26	The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. The anxiety item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the anxiety item score was set to missing. Negative change in scores indicates improvement. MMRM was used for analysis.
Secondary	Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Sadness or Depression (Item 9) Score at Week 26	Baseline, Week 26	The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. The sadness or depression item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the item score was set to missing. Negative change in scores indicates improvement. MMRM was used for analysis.
Secondary	Change From Baseline in Individual Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Scores at Week 26	Baseline, Week 26	The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. Negative change in scores indicates improvement. MMRM was used for analysis.
Secondary	Number of Participants With Response at Week 26 [Early Termination (ET)]	Baseline up to Week 26	Response was defined as a 30% reduction in HypoPT-SD symptom subscale score from baseline. The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4; and for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The symptom subscale score was computed as the average of symptom items 1-7 scores with more than 3 of the 7 symptom item scores were non-missing. Data reported also includes results for early terminated participants.
Secondary	Change From Baseline in the Most Bothersome Symptom Score at Week 26	Baseline, Week 26	The HypoPT-SD is a 13-item patient-reported outcomes instrument that consists of the following items: symptom subscale (items 1-7), anxiety (item 8), sadness or depression (item 9) and impact subscale (items 10-13). For items 1-9, the individual score ranges from None=0 to Very severe=4 and for items 10-13, it ranges from Not at all=0 to Very much=2. An item score was computed by taking the average of the daily item response over the 14-day period immediately before the visit. If data were not available for at least 4 out of 7 days during both 7-day periods within the 14-day period, the individual item score was set to missing. The Most Bothersome Symptom Score was analyzed. Negative change in scores indicates improvement. MMRM was used for analysis.

1 to 10 of 29Source ClinicalTrials.gov

See all 29 registered outcomes

Outcomes29

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Subscale Score at Week 26	Baseline, Week 26	ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 26	Baseline, Week 26	ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Physical Component Summary (PCS) Derived From 36-Item Short Form Health Survey Version 2 (SF-36v2) Scores at Week 26	Baseline, Week 26	ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Impact Subscale Score at Week 26	Baseline, Week 26	ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Individual Hypoparathyroidism Symptom Diary (HypoPT-SD) Impact Items Score at Week 26	Baseline, Week 26	ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Anxiety (Item 8) Score at Week 26	Baseline, Week 26	ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Sadness or Depression (Item 9) Score at Week 26	Baseline, Week 26	ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Individual Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Item Scores at Week 26	Baseline, Week 26	ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Response at Week 26 [Early Termination (ET)]	Baseline up to Week 26	ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in the Most Bothersome Symptom Score at Week 26	Baseline, Week 26	ITT Set included all randomized participants. Overall number analyzed is the number of participants with data available at the time of analyses.	score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 29Source ClinicalTrials.gov

See all 29 outcomes

Results by group116

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Subscale Score at Week 26	Placebo		-0.93	Standard Error 0.130	score on a scale
Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Symptom Subscale Score at Week 26	rhPTH (1-84)		-1.46	Standard Error 0.137	score on a scale
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 26	Placebo		4.4	Standard Error 1.87	score on a scale
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 26	rhPTH (1-84)		15.0	Standard Error 1.93	score on a scale
Change From Baseline in Physical Component Summary (PCS) Derived From 36-Item Short Form Health Survey Version 2 (SF-36v2) Scores at Week 26	Placebo		4.404	Standard Error 1.3514	score on a scale
Change From Baseline in Physical Component Summary (PCS) Derived From 36-Item Short Form Health Survey Version 2 (SF-36v2) Scores at Week 26	rhPTH (1-84)		8.646	Standard Error 1.3406	score on a scale
Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Impact Subscale Score at Week 26	Placebo		-0.36	Standard Error 0.076	score on a scale
Change From Baseline in Hypoparathyroidism Symptom Diary (HypoPT-SD) Impact Subscale Score at Week 26	rhPTH (1-84)		-0.69	Standard Error 0.081	score on a scale
Change From Baseline in Individual Hypoparathyroidism Symptom Diary (HypoPT-SD) Impact Items Score at Week 26	Placebo	Impact on Sleep	-0.39	Standard Error 0.086	score on a scale
Change From Baseline in Individual Hypoparathyroidism Symptom Diary (HypoPT-SD) Impact Items Score at Week 26	rhPTH (1-84)	Impact on Sleep	-0.68	Standard Error 0.090	score on a scale

1 to 10 of 116Source ClinicalTrials.gov

See all 116 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	48
Overall Study	STARTED	rhPTH (1-84)	45
Overall Study	COMPLETED	Placebo	46
Overall Study	COMPLETED	rhPTH (1-84)	39
Overall Study	NOT COMPLETED	Placebo	2
Overall Study	NOT COMPLETED	rhPTH (1-84)	6

Source ClinicalTrials.gov

Adverse events76

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	Placebo	3	48
other	Abdominal pain	Gastrointestinal disorders	rhPTH (1-84)	1	45
other	Anxiety	Psychiatric disorders	Placebo	3	48
other	Anxiety	Psychiatric disorders	rhPTH (1-84)	4	45
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	6	48
other	Arthralgia	Musculoskeletal and connective tissue disorders	rhPTH (1-84)	8	45
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	2	48
other	Back pain	Musculoskeletal and connective tissue disorders	rhPTH (1-84)	4	45
other	Bone pain	Musculoskeletal and connective tissue disorders	Placebo	3	48
other	Bone pain	Musculoskeletal and connective tissue disorders	rhPTH (1-84)	3	45

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	48
Total, all-cause mortality	rhPTH (1-84)	0	45
Total, other adverse events	Placebo	41	48
Total, other adverse events	rhPTH (1-84)	38	45
Total, serious adverse events	Placebo	6	48
Total, serious adverse events	rhPTH (1-84)	6	45

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
40711996	DERIVED	PubMed
41847596	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
rhPTH (1-84) vs Placebo: Number of Participants With Response at Week 26 [Early Termination (ET)]	Trial comparisons
rhPTH (1-84) vs Placebo: Number of Participants Who Achieve Composite Criteria for Albumin-corrected Serum Calcium Concentration, Active Vitamin D Dose and Oral Elemental Calcium Supplement Dose at Week 26	Trial comparisons
rhPTH (1-84) vs Placebo: deaths from any cause	Trial comparisons
rhPTH (1-84) vs Placebo: Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Trial comparisons
rhPTH (1-84) vs Placebo: serious adverse events	Trial comparisons

Tests2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
1-Back Task	Secondary outcome	ConductCognition
Hidden Path Learning	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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